An interventional study of PrEP eligibility assessment and Rapid HIV antibody testing prior to provision and/or refill of PrEP in HIV Infection, Sexually Transmitted Infections and Pre-exposure Prophylaxis, sponsored by HIV Prevention Trials Network. Completed at 1 site in Malawi. Open to male participants aged 15 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by HIV Prevention Trials Network · Not applicable, Interventional, and Prevention
Among 13 studies in HIV Infections by HIV Prevention Trials Network — 3 open to participants now, 3 under way, 1 of them phase 3. HIV Infections · HIV Prevention Trials Network.
Among the 13 studies in HIV Infections by HIV Prevention Trials Network, this one is the 10th largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2024, is one of 7 with no phase, and was the 11th registered.
4,735 studies on the registry are indexed under HIV Infections; 245 are open to participants now.
Browse HIV Infections studies →3 of the 13 studies in HIV Infections by HIV Prevention Trials Network are open now, in 7 countries. Recruiting first, the newest first:
HIV Prevention Trials Network · Sites in United States
Ages 15+ · Men only · Healthy volunteers
HIV Prevention Trials Network · Sites in United States, Argentina, Brazil and 1 more country
Ages 18–29 · Men only · Healthy volunteers
HIV Prevention Trials Network · Sites in Eswatini, Uganda, Zimbabwe
Ages 16–39 · Women only · Healthy volunteers
By country, each count listing its studies:
Of the 159 HIV Infections studies recruiting now, 104 (65%) set no upper age limit and 42 (26%) stop at 75 or younger; 31 take children under 18; 60 take healthy volunteers.
This study: 15 Years and older · male · healthy volunteers too.
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13 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2024.
This study's enrollment of 215 is above the median of 80 across 3,490 interventional studies indexed under HIV Infections.
Median enrollment 447 across the 11 interventional studies, 1,585 across the 2 observational. Of the 10 that completed or were terminated, 4 (40%) have results posted.
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HIV Prevention Trials Network is the lead sponsor of 24 studies on the registry; 4 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 13 studies in HIV Infections by HIV Prevention Trials Network, from their registry updates:
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To evaluate the potential benefit(s), acceptability, and associated costs of a systems navigator-delivered HIV prevention intervention in promoting and supporting persistent use of evidence-based HIV pre-exposure prophylaxis (PrEP) among heterosexual men receiving care for sexually transmitted infections (STIs) in Lilongwe, Malawi.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adult and adolescent men who meet all of the following criteria are eligible for inclusion in this study as a participant initiating PrEP:
Individuals who meet all of the following criteria are eligible for inclusion in this study as other key stakeholders:
Exclusion Criteria:
Adult and adolescent men who meet any of the following criteria are ineligible for inclusion in this study as a participant initiating PrEP:
Individuals who meet any of the following criteria are ineligible for inclusion in this study as other key stakeholder:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard of care (SOC) PrEP services include PrEP eligibility assessment, rapid HIV antibody testing prior to provision and/or refill of PrEP, and PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines. Specifically, SOC services do not generally include point of contact STI testing (with the exception of rapid syphilis and Hepatitis B antigen testing, if kits are available, at PrEP initiation) nor tracing for missed PrEP visits. Participants randomized to the SOC condition will receive these standard PrEP services.
Other: PrEP eligibility assessment · Diagnostic Test: Rapid HIV antibody testing prior to provision and/or refill of PrEP · Other: PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines
The intervention package is integrated into PrEP visits and includes evaluation of barriers and facilitators to ongoing PrEP use, point of contact STI testing to inform counseling regarding ongoing PrEP care engagement, tracing for any missed PrEP visits, and offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period. Recognizing increasingly cyclical PrEP use patterns, navigators serve as a direct entry point to retain or re-engage participants in HIV prevention care.
Other: PrEP eligibility assessment · Diagnostic Test: Rapid HIV antibody testing prior to provision and/or refill of PrEP · Other: PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines · Behavioral: Evaluation of barriers and facilitators to ongoing PrEP use · Other: Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement · Other: Tracing for any missed PrEP visits · Other: Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period
PrEP eligibility assessment
Rapid HIV antibody testing prior to provision and/or refill of PrEP
PrEP follow-up with a PrEP nurse in accordance with contemporary PrEP guidelines
Evaluation of barriers and facilitators to ongoing PrEP use
Point of contact STI testing to inform counseling regarding ongoing PrEP care engagement
Tracing for any missed PrEP visits
Offering a PrEP "restart" kit for men who choose to discontinue PrEP during the follow-up period
Efficacy: Persistent PrEP Use Across All Three Modalities (LAI, Daily Oral, or Event-driven PrEP)
Consistent with this primary study objective, the following endpoint(s) will be assessed: Persistent PrEP use across all three modalities (LAI, daily oral, or event-driven PrEP), where persistence is defined as adherence to any PrEP modality through 26 weeks, comparing percentage in intervention and control arm participants. (LAI) receive on-time injections (+/- 7-day window for the first injection and 14-day window thereafter) (Daily Oral) have protective PrEP concentration detected at designated study follow-up visits, based on intraerythrocytic TFVDP collected as DBS; TFV-DP concentrations associated with ≥4 doses/week will be classified as adherent. (Event-driven) self-reported PrEP adherence (2+1+1), in the past 30 days, assessed through self-report of PrEP use and sex acts at study follow-up visits, and intraerythrocytic TFV-DP concentrations.
Time frame: 26 weeks
Acceptability: Percentage of Intervention Arm Participants Engaged by Systems Navigator Within 7-days of Enrollment Visit
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Percentage of intervention arm participants engaged by systems navigator within 7-days of enrollment visit (defined as any contact, i.e. text exchange, in-person communication)
Time frame: 7 days
Acceptability: Percentage of Intervention Arm Participants Engaged by Systems Navigators at Least Once After the Initial Engagement During the First 26 Weeks Following Initiation of PrEP.
Consistent with this primary study objective, the following endpoint(s) will be assessed among participants in the intervention arm only: Engagement with system navigators: Overall: Percentage of intervention arm participants engaged by systems navigators at least once after the initial engagement during the first 26 weeks following initiation of PrEP.
Time frame: 26 weeks
Acceptability: Percentage of Intervention Arm Participants With Attempted Engagement by Systems Navigators at Least Once After the Initial Engagement During the First 26 Weeks Following Initiation of PrEP.
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Percentage of intervention arm participants with attempted engagement by systems navigators at least once after the initial engagement during the first 26 weeks following initiation of PrEP.
Time frame: 26 weeks
Acceptability: Mean (Standard Error) Number of Contacts (Text, Telephone Call, Home Visit, Other) With Intervention Arm Participants Made With Systems Navigators (Mean Contacts Per Participant) During First 26 Weeks Following Initiation of PrEP.
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Mean (standard error) number of contacts (text, telephone call, home visit, other) with intervention arm participants made with systems navigators (mean contacts per participant) during first 26 weeks following initiation of PrEP.
Time frame: 26 weeks
Acceptability: Percentage Who Self-report Use of HIV Self-test
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Uptake of self-test/pill pack ("re-start" kit) among those to whom it is distributed (through end of study participation): Percentage who self-report use of HIV self-test
Time frame: Up to 52 weeks
Acceptability: Percentage Who Self-report Use of PrEP Pill Pack
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Uptake of self-test/pill pack ("re-start" kit) among those to whom it is distributed (through end of study participation): Percentage who self-report use of PrEP pill pack.
Time frame: Up to 52 weeks
Acceptability: Percentage Who Self-report Use of HIV Self-test in Conjunction With/Prior to Initiation of PrEP Pill Pack
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Uptake of self-test/pill pack ("re-start" kit) among those to whom it is distributed (through end of study participation): Percentage who self-report use of HIV self-test in conjunction with/prior to initiation of PrEP pill pack.
Time frame: Up to 52 weeks
Acceptability: Survey - The Systems Navigation Intervention Meets my Approval. (Week 13)
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: The systems navigation intervention meets my approval. (Week 13)
Time frame: 13 weeks
Acceptability: Survey - The Systems Navigation Intervention Meets my Approval. (Week 26)
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: The systems navigation intervention meets my approval. (Week 26)
Time frame: 26 weeks
Acceptability: Survey - The Systems Navigation Intervention is Appealing to me. (Week 13)
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: The systems navigation intervention is appealing to me. (Week 13)
Time frame: 13 weeks
Acceptability: Survey - The Systems Navigation Intervention is Appealing to me. (Week 26)
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: The systems navigation intervention is appealing to me. (Week 26)
Time frame: 26 weeks
Acceptability: Survey - I Like the Systems Navigation Intervention. (Week 13)
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: I like the systems navigation intervention. (Week 13)
Time frame: 13 weeks
Acceptability: Survey - I Like the Systems Navigation Intervention. (Week 26)
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: I like the systems navigation intervention. (Week 26)
Time frame: 26 weeks
Acceptability: Survey - I Welcome the Systems Navigation Intervention. (Week 13)
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: I welcome the systems navigation intervention. (Week 13)
Time frame: 13 weeks
Acceptability: Survey - I Welcome the Systems Navigation Intervention. (Week 26)
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: I welcome the systems navigation intervention. (Week 26)
Time frame: 26 weeks
Acceptability: In-depth Interviews - Prioritization of Heterosexual Men.
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Prioritization of heterosexual men.
Time frame: At in-depth interview, an average of 10 months after study start-up
Acceptability: In-depth Interviews - Fit With National Priorities.
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Fit with national priorities.
Time frame: At in-depth interview, an average of 10 months after study start-up
Acceptability: In-depth Interviews - Perception of Tracing for Missed PrEP Visits.
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Perception of tracing for missed PrEP visits.
Time frame: At in-depth interview, an average of 10 months after study start-up
Acceptability: In-depth Interviews - Perception of Restart Kits for Persons Who Stop PrEP.
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Perception of restart kits for persons who stop PrEP.
Time frame: At in-depth interview, an average of 10 months after study start-up
Acceptability: In-depth Interviews - Navigator Traits and Training.
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Navigator traits and training.
Time frame: At in-depth interview (at final study visit, up to 52 weeks)
Acceptability: In-depth Interviews - STI Testing Integration With PrEP Services.
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: STI Testing Integration with PrEP services.
Time frame: At in-depth interview (at final study visit, up to 52 weeks)
Acceptability: In-depth Interviews - In-person Tracing for Missed PrEP Visits.
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: In-person tracing for missed PrEP visits.
Time frame: At in-depth interview (at final study visit, up to 52 weeks)
Acceptability: In-depth Interviews - Perception of Restart Kit Provision for Persons Who Stop PrEP.
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Perception of restart kit provision for persons who stop PrEP.
Time frame: At in-depth interview (at final study visit, up to 52 weeks)
Feasibility: Calendar Time to Enroll Participants
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Calendar time to enroll participants
Time frame: Enrollment period
Feasibility: Percentage of Participants Retained at Each [Eligible] Study Visit
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT participants: Percentage of participants retained at each \[eligible\] study visit This study followed a staggered enrollment. Participants who are enrolled within 13 weeks during the first enrollment period were expected to complete study visits Weeks 13, 26, 39, and 52. Those enrolled 13 weeks after, but within the first 26 weeks after the first enrollment period were expected to complete study visits Weeks 13, 26, and 39. Those enrolled 26 weeks after the first enrollment period were only expected to complete study visits Weeks 13 and 26.
Time frame: Up to 52 weeks
Feasibility: Complete All Study Visits Through 26 Weeks, 39 Weeks, and 52 Weeks (Among Participants Eligible for Longer Follow-up) - Target Window
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Complete all study visits through 26 weeks, 39 weeks, and 52 weeks (among participants eligible for longer follow-up) within the target window. This study followed a staggered enrollment. Participants who are enrolled within 13 weeks during the first enrollment period were expected to complete study visits Weeks 13, 26, 39, and 52. Those enrolled 13 weeks after, but within the first 26 weeks after the first enrollment period were expected to complete study visits Weeks 13, 26, and 39. Those enrolled 26 weeks after the first enrollment period were only expected to complete study visits Weeks 13 and 26. Target windows (inclusive from enrollment) are defined as: Week 13: Days 71 to 112, Week 26: Days 161 to 203, Week 39: Days 252 to 294, Week 52: Days 344 to 386.
Time frame: Up to 52 weeks
Feasibility: Complete All Study Visits Through 26 Weeks, 39 Weeks, and 52 Weeks (Among Participants Eligible for Longer Follow-up) - Allowable Window
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Complete all study visits through 26 weeks, 39 weeks, and 52 weeks (among participants eligible for longer follow-up) within the allowable window. This study followed a staggered enrollment. Participants who are enrolled within 13 weeks during the first enrollment period were expected to complete study visits Weeks 13, 26, 39, and 52. Those enrolled 13 weeks after, but within the first 26 weeks after the first enrollment period were expected to complete study visits Weeks 13, 26, and 39. Those enrolled 26 weeks after the first enrollment period were only expected to complete study visits Weeks 13 and 26. Allowable windows (inclusive from enrollment) are defined as: Week 13: Days 70 to 153, Week 26: Days 154 to 244, Week 39: Days 245 to 336, Week 52: Days 337 to 427.
Time frame: Up to 52 weeks
Feasibility: Percentage of PrEP Visits on the Same Day as Study Visits, by PrEP Modality.
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Percentage of PrEP visits on the same day as study visits, by PrEP modality.
Time frame: Up to 52 weeks
Feasibility: Percentage of Participants Completing 30-day Timeline Follow-back at Quarterly Study Visits
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Percentage of participants completing 30-day Timeline Follow-back at quarterly study visits. Participants who are enrolled within 13 weeks during the first enrollment period were expected to complete study visits Weeks 13, 26, 39, and 52. Those enrolled 13 weeks after, but within the first 26 weeks after the first enrollment period were expected to complete study visits Weeks 13, 26, and 39. Those enrolled 26 weeks after the first enrollment period were only expected to complete study visits Weeks 13 and 26. This includes all ITT participants who completed each particular visit.
Time frame: Up to 52 weeks
Feasibility: Time to Complete Each Study Visit
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Time to complete each study visit.
Time frame: Up to 52 weeks
Feasibility: Additional Time (at PrEP Visits) Engaging With Systems Navigators
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Additional time (at PrEP visits) engaging with systems navigators
Time frame: Up to 52 weeks
200 participants from a single site were screened. Additionally, 15 key stakeholders relevant to systems navigation program implementation were recruited for a single qualitative interview.
| Milestone | Standard of Care | Intervention | Key Stakeholders Only |
|---|---|---|---|
| Started | 67 | 133 | 15 |
| Prep only | 57 | 118 | 0 |
| Prep + in-depth interview | 10 | 15 | 0 |
| Completed | 57 | 112 | 15 |
| Not completed | 10 | 21 | 0 |
| Withdrew: Death | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 9 | 19 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 0 |
| Withdrew: Enrollment violation | 1 | 0 | 0 |
| Milestone | Standard of Care | Intervention | Key Stakeholders Only |
|---|---|---|---|
| Started | 40 | 75 | 15 |
| Prep only | 36 | 69 | 0 |
| Prep + in-depth interview | 4 | 6 | 0 |
| Completed | 38 | 72 | 15 |
| Not completed | 2 | 3 | 0 |
| Withdrew: Lost to follow-up | 2 | 3 | 0 |
| Milestone | Standard of Care | Intervention | Key Stakeholders Only |
|---|---|---|---|
| Started | 20 | 39 | 15 |
| Prep only | 18 | 39 | 0 |
| Prep + in-depth interview | 2 | 0 | 0 |
| Completed | 20 | 39 | 15 |
| Not completed | 0 | 0 | 0 |
Consistent with this primary study objective, the following endpoint(s) will be assessed: Persistent PrEP use across all three modalities (LAI, daily oral, or event-driven PrEP), where persistence is defined as adherence to any PrEP modality through 26 weeks, comparing percentage in intervention and control arm participants. (LAI) receive on-time injections (+/- 7-day window for the first injection and 14-day window thereafter) (Daily Oral) have protective PrEP concentration detected at designated study follow-up visits, based on intraerythrocytic TFVDP collected as DBS; TFV-DP concentrations associated with ≥4 doses/week will be classified as adherent. (Event-driven) self-reported PrEP adherence (2+1+1), in the past 30 days, assessed through self-report of PrEP use and sex acts at study follow-up visits, and intraerythrocytic TFV-DP concentrations.
| Participants | Standard of Care | Intervention |
|---|---|---|
| Efficacy: Persistent PrEP Use Across All Three Modalities (LAI, Daily Oral, or Event-driven PrEP) | 8 | 9 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Percentage of intervention arm participants engaged by systems navigator within 7-days of enrollment visit (defined as any contact, i.e. text exchange, in-person communication)
| Participants | Intervention |
|---|---|
| Acceptability: Percentage of Intervention Arm Participants Engaged by Systems Navigator Within 7-days of Enrollment Visit | 129 |
Consistent with this primary study objective, the following endpoint(s) will be assessed among participants in the intervention arm only: Engagement with system navigators: Overall: Percentage of intervention arm participants engaged by systems navigators at least once after the initial engagement during the first 26 weeks following initiation of PrEP.
| Participants | Intervention |
|---|---|
| Acceptability: Percentage of Intervention Arm Participants Engaged by Systems Navigators at Least Once After the Initial Engagement During the First 26 Weeks Following Initiation of PrEP. | 118 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Percentage of intervention arm participants with attempted engagement by systems navigators at least once after the initial engagement during the first 26 weeks following initiation of PrEP.
| Participants | Intervention |
|---|---|
| Acceptability: Percentage of Intervention Arm Participants With Attempted Engagement by Systems Navigators at Least Once After the Initial Engagement During the First 26 Weeks Following Initiation of PrEP. | 129 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Engagement with system navigators: Mean (standard error) number of contacts (text, telephone call, home visit, other) with intervention arm participants made with systems navigators (mean contacts per participant) during first 26 weeks following initiation of PrEP.
| Number of successful contacts | Intervention |
|---|---|
| Acceptability: Mean (Standard Error) Number of Contacts (Text, Telephone Call, Home Visit, Other) With Intervention Arm Participants Made With Systems Navigators (Mean Contacts Per Participant) During First 26 Weeks Following Initiation of PrEP. | 4.8 ± 2.25 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Uptake of self-test/pill pack ("re-start" kit) among those to whom it is distributed (through end of study participation): Percentage who self-report use of HIV self-test
| Participants | Intervention |
|---|---|
| Acceptability: Percentage Who Self-report Use of HIV Self-test | 26 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Uptake of self-test/pill pack ("re-start" kit) among those to whom it is distributed (through end of study participation): Percentage who self-report use of PrEP pill pack.
| Participants | Intervention |
|---|---|
| Acceptability: Percentage Who Self-report Use of PrEP Pill Pack | 3 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Uptake of self-test/pill pack ("re-start" kit) among those to whom it is distributed (through end of study participation): Percentage who self-report use of HIV self-test in conjunction with/prior to initiation of PrEP pill pack.
| Participants | Intervention |
|---|---|
| Acceptability: Percentage Who Self-report Use of HIV Self-test in Conjunction With/Prior to Initiation of PrEP Pill Pack | 3 |
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Calendar time to enroll participants
| Days | Intent-to-Treat (ITT) |
|---|---|
| Feasibility: Calendar Time to Enroll Participants | 227 |
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT participants: Percentage of participants retained at each \[eligible\] study visit This study followed a staggered enrollment. Participants who are enrolled within 13 weeks during the first enrollment period were expected to complete study visits Weeks 13, 26, 39, and 52. Those enrolled 13 weeks after, but within the first 26 weeks after the first enrollment period were expected to complete study visits Weeks 13, 26, and 39. Those enrolled 26 weeks after the first enrollment period were only expected to complete study visits Weeks 13 and 26.
| Participants | Standard of Care | Intervention |
|---|---|---|
| Week 13 | 58 | 116 |
| Week 26 | 58 | 112 |
| Week 39 | 40 | 75 |
| Week 52 | 20 | 39 |
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Complete all study visits through 26 weeks, 39 weeks, and 52 weeks (among participants eligible for longer follow-up) within the target window. This study followed a staggered enrollment. Participants who are enrolled within 13 weeks during the first enrollment period were expected to complete study visits Weeks 13, 26, 39, and 52. Those enrolled 13 weeks after, but within the first 26 weeks after the first enrollment period were expected to complete study visits Weeks 13, 26, and 39. Those enrolled 26 weeks after the first enrollment period were only expected to complete study visits Weeks 13 and 26. Target windows (inclusive from enrollment) are defined as: Week 13: Days 71 to 112, Week 26: Days 161 to 203, Week 39: Days 252 to 294, Week 52: Days 344 to 386.
| Participants | Standard of Care | Intervention |
|---|---|---|
| Week 26 | 43 | 71 |
| Week 39 | 28 | 53 |
| Week 52 | 13 | 24 |
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Complete all study visits through 26 weeks, 39 weeks, and 52 weeks (among participants eligible for longer follow-up) within the allowable window. This study followed a staggered enrollment. Participants who are enrolled within 13 weeks during the first enrollment period were expected to complete study visits Weeks 13, 26, 39, and 52. Those enrolled 13 weeks after, but within the first 26 weeks after the first enrollment period were expected to complete study visits Weeks 13, 26, and 39. Those enrolled 26 weeks after the first enrollment period were only expected to complete study visits Weeks 13 and 26. Allowable windows (inclusive from enrollment) are defined as: Week 13: Days 70 to 153, Week 26: Days 154 to 244, Week 39: Days 245 to 336, Week 52: Days 337 to 427.
| Participants | Standard of Care | Intervention |
|---|---|---|
| Week 26 | 49 | 93 |
| Week 39 | 35 | 62 |
| Week 52 | 15 | 33 |
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Percentage of PrEP visits on the same day as study visits, by PrEP modality.
| PrEP_Visits | Standard of Care | Intervention |
|---|---|---|
| PrEP modality: LAI | 11 | 26 |
| PrEP modality: Daily oral | 48 | 134 |
| PrEP modality: Event-driven | 4 | 6 |
| PrEP modality: None | 0 | 11 |
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Percentage of participants completing 30-day Timeline Follow-back at quarterly study visits. Participants who are enrolled within 13 weeks during the first enrollment period were expected to complete study visits Weeks 13, 26, 39, and 52. Those enrolled 13 weeks after, but within the first 26 weeks after the first enrollment period were expected to complete study visits Weeks 13, 26, and 39. Those enrolled 26 weeks after the first enrollment period were only expected to complete study visits Weeks 13 and 26. This includes all ITT participants who completed each particular visit.
| Participants | Standard of Care | Intervention |
|---|---|---|
| Enrollment | 66 | 129 |
| Week 13 | 50 | 101 |
| Week 26 | 55 | 104 |
| Week 39 | 36 | 71 |
| Week 52 | 20 | 39 |
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Time to complete each study visit.
No measurements were reported for this outcome.
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: The systems navigation intervention meets my approval. (Week 13)
| Participants | Intervention |
|---|---|
| Completely Agree | 38 |
| Agree | 62 |
| Neither agree nor disagree | 1 |
| Disagree | 0 |
| Completely disagree | 0 |
| Decline to answer | 0 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: The systems navigation intervention meets my approval. (Week 26)
| Participants | Intervention |
|---|---|
| Completely Agree | 34 |
| Agree | 59 |
| Neither agree nor disagree | 10 |
| Disagree | 0 |
| Completely disagree | 0 |
| Decline to answer | 1 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: The systems navigation intervention is appealing to me. (Week 13)
| Participants | Intervention |
|---|---|
| Completely Agree | 40 |
| Agree | 60 |
| Neither agree nor disagree | 1 |
| Disagree | 0 |
| Completely disagree | 0 |
| Decline to answer | 0 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: The systems navigation intervention is appealing to me. (Week 26)
| Participants | Intervention |
|---|---|
| Completely Agree | 35 |
| Agree | 59 |
| Neither agree nor disagree | 10 |
| Disagree | 0 |
| Completely disagree | 0 |
| Decline to answer | 0 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: I like the systems navigation intervention. (Week 13)
| Participants | Intervention |
|---|---|
| Completely Agree | 41 |
| Agree | 59 |
| Neither agree nor disagree | 1 |
| Disagree | 0 |
| Completely disagree | 0 |
| Decline to answer | 0 |
Consistent with this secondary study objective, the following endpoint will be assessed amongst the ITT population: Additional time (at PrEP visits) engaging with systems navigators
| Systems_Navigation_Visits | Intervention |
|---|---|
| 0-14 minutes | 3 |
| 15-29 minutes | 194 |
| 30-44 minutes | 117 |
| 45-60 minutes | 64 |
| More than 1 hour | 10 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: I like the systems navigation intervention. (Week 26)
| Participants | Intervention |
|---|---|
| Completely Agree | 32 |
| Agree | 61 |
| Neither agree nor disagree | 10 |
| Disagree | 1 |
| Completely disagree | 0 |
| Decline to answer | 0 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: I welcome the systems navigation intervention. (Week 13)
| Participants | Intervention |
|---|---|
| Completely Agree | 40 |
| Agree | 60 |
| Neither agree nor disagree | 1 |
| Disagree | 0 |
| Completely disagree | 0 |
| Decline to answer | 0 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Acceptability based on quantitative surveys (participants enrolled as seronegative PrEP initiators only) Question: I welcome the systems navigation intervention. (Week 26)
| Participants | Intervention |
|---|---|
| Completely Agree | 31 |
| Agree | 62 |
| Neither agree nor disagree | 10 |
| Disagree | 0 |
| Completely disagree | 0 |
| Decline to answer | 1 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Prioritization of heterosexual men.
| Participants | Key Stakeholders |
|---|---|
| Favorable | 6 |
| Dissenting | 1 |
| Mixed opinion | 8 |
| Topic not discussed | 0 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Fit with national priorities.
| Participants | Key Stakeholders |
|---|---|
| Favorable | 2 |
| Dissenting | 2 |
| Mixed opinion | 2 |
| Topic not discussed | 9 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Perception of tracing for missed PrEP visits.
| Participants | Key Stakeholders |
|---|---|
| Favorable | 4 |
| Dissenting | 1 |
| Mixed opinion | 7 |
| Topic not discussed | 3 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Perception of restart kits for persons who stop PrEP.
| Participants | Key Stakeholders |
|---|---|
| Favorable | 2 |
| Dissenting | 2 |
| Mixed opinion | 11 |
| Topic not discussed | 0 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Navigator traits and training.
| Participants | In-depth Interview - Intervention Arm Only |
|---|---|
| Favorable | 12 |
| Dissenting | 0 |
| Mixed opinion | 3 |
| Topic not discussed | 0 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: STI Testing Integration with PrEP services.
| Participants | In-depth Interview - Intervention Arm Only |
|---|---|
| Favorable | 7 |
| Dissenting | 0 |
| Mixed opinion | 2 |
| Topic not discussed | 6 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: In-person tracing for missed PrEP visits.
| Participants | In-depth Interview - Intervention Arm Only |
|---|---|
| Favorable | 11 |
| Dissenting | 0 |
| Mixed opinion | 0 |
| Topic not discussed | 4 |
Consistent with this primary study objective, the following endpoint will be assessed among participants in the intervention arm only: Acceptability and barriers among key stakeholders, including participants enrolled as seronegative PrEP initiators and other key stakeholders: Perceived facilitators and barriers to implementation of the intervention will be assessed through individual semi-structured interviews. Topic: Perception of restart kit provision for persons who stop PrEP.
| Participants | In-depth Interview - Intervention Arm Only |
|---|---|
| Favorable | 1 |
| Dissenting | 0 |
| Mixed opinion | 1 |
| Topic not discussed | 13 |
Collected over From enrollment until end of follow-up, up to 52 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care | 0/67 (0%) | — | — |
| Intervention | 1/133 (0.8%) | — | — |
Key Stakeholders completed a single qualitative interview. No information was systemically collected on CRFs or in a database. As a result, no demographic information was collected.
| Age, Continuous(Years) | Standard of Care | Intervention | Total |
|---|---|---|---|
| Median | 26 (24 to 30) | 28 (24 to 34) | 27 (24 to 33) |
| Age, Customized(Participants) | Standard of Care | Intervention | Total |
|---|---|---|---|
| Age (years) — 15-25 | 29 | 53 | 82 |
| Age (years) — >25 | 38 | 80 | 118 |
| Sex: Female, Male(Participants) | Standard of Care | Intervention | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 67 | 133 | 200 |
| Race/Ethnicity, Customized(Participants) | Standard of Care | Intervention | Total |
|---|---|---|---|
| Race — Black | 67 | 133 | 200 |
| Race — White | 0 | 0 | 0 |
| Race — Indian | 0 | 0 | 0 |
| Race — Asian | 0 | 0 | 0 |
| Race — Colored/Mixed | 0 | 0 | 0 |
| Race — Other | 0 | 0 | 0 |
| Race — Decline to answer | 0 | 0 | 0 |
| Baseline PrEP Modality(Participants) | Standard of Care | Intervention | Total |
|---|---|---|---|
| Daily Oral PrEP | 50 | 105 | 155 |
| Event-driven PrEP | 5 | 8 | 13 |
| Injectable PrEP | 12 | 20 | 32 |
| Any STI positive status (syphilis, gonorrhea, chlamydia)(Participants) | Standard of Care | Intervention | Total |
|---|---|---|---|
| Positive | 35 | 69 | 104 |
| Negative | 32 | 64 | 96 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Apr 2024 to primary completion in Jul 2025, 15 months.
Results were first posted in Nov 2026, 1 year 3 months after primary completion.
Of 393 non-industry interventional studies with no phase under HIV Infections, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 45. This study's 15 months is below that.
Counting every sponsor, half of 402 studies reached it within 28 months; a quarter within 16 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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