An interventional study of Assisted Partner Services in HIV/AIDS and Hepatitis C, sponsored by University of Washington. Completed at 3 sites in Kenya. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-21.
Sponsored by University of Washington · Not applicable, Interventional, and Diagnostic
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Among 38 studies in Acquired Immunodeficiency Syndrome by University of Washington — 7 open to participants now, 10 under way, none of them phase 3. Acquired Immunodeficiency Syndrome · University of Washington.
Among the 38 studies in Acquired Immunodeficiency Syndrome by University of Washington, this one is the 4th largest by enrollment of the 35 interventional ones that give a count, is one of 3 that started in 2018, is one of 30 with no phase, and was the 15th registered.
3,037 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 307 are open to participants now.
Browse Acquired Immunodeficiency Syndrome studies →7 of the 38 studies in Acquired Immunodeficiency Syndrome by University of Washington are open now, in 2 countries. Recruiting first, the newest first:
University of Washington · Sites in Uganda
Ages 15+ · Healthy volunteers
University of Washington · Sites in Kenya
Ages 15+ · Healthy volunteers
University of Washington · Sites in Kenya
Ages 18–50 · Women only
University of Washington · Sites in Kenya
Women only · Healthy volunteers
University of Washington · Sites in Kenya
Healthy volunteers
By country, each count listing its studies:
Of the 198 Acquired Immunodeficiency Syndrome studies recruiting now, 118 (60%) set no upper age limit and 67 (34%) stop at 75 or younger; 43 take children under 18; 68 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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38 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 3 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 4,301 is above the median of 96 across 2,252 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Median enrollment 360 across the 35 interventional studies, 850 across the 3 observational. Of the 27 that completed or were terminated, 14 (52%) have results posted.
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University of Washington is the lead sponsor of 1,434 studies on the registry; 226 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.
1 of the studies in Acquired Immunodeficiency Syndrome by University of Washington that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05467306University of WashingtonEnhancing PrEP Outcomes Among Kenyan Adolescent Girls and Young Women With a Novel Pharmacy-based PrEP Delivery Platform | 2027-03-31 |
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Among the 38 studies in Acquired Immunodeficiency Syndrome by University of Washington, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study will determine whether assisted partner notification services (APS) can identify and link to care, the sexual and needle-sharing partners of HIV-infected and HIV/hepatitis C (HCV) co-infected persons who inject drugs (PWID). It will also define the risk factors for onward HIV and HCV transmission among PWID using viral phylogenetics.
Overview: This NIH-funded study uses assisted partner services (APS) to identify HIV-infected and HCV-infected persons who inject drugs (PWID) in Kenya and link them to care. In addition to determining the role of APS in HIV and HCV case-finding for this hard-to-reach key population, we leverage our experience with HIV and HCV phylogenetics in the US and South Africa to define modes and risk factors for onward viral transmission. The specific aims of the proposal are as follows:
AIM 1. To determine whether contact tracing and partner notification practices, known in Kenya as assisted partner services (APS), can identify and link to care, the sexual and injection partners of HIV-infected and HIV/ hepatitis C (HCV) co-infected persons who inject drugs (PWID).
AIM 2. To define the risk factors for HIV transmission among PWID, and to elucidate the role of PWID in the overall Kenyan HIV epidemic, using viral genetic sequencing techniques.
AIM 3. To characterize the modes and risk factors for onward HCV transmission among PWID using viral genetic sequencing.
Design: We will enroll 1000 HIV-infected PWID through a needle and syringe exchange program (NSP) in Nairobi, Kenya. Each index participant will undergo a structured questionnaire, a rapid HCV test, a blood draw, and will provide locator information regarding their sexual and injection partners from the past 3 years. Study staff will then attempt to locate all partners. Once located, partner participants will undergo rapid HIV and HCV testing, a structured questionnaire, and a blood draw. All blood samples will be sent to a central laboratory in Nairobi for processing. Dried blood spot samples will be created in Nairobi and will later be sent to the University of KwaZulu-Natal for quantitative viral loads for both HIV and hepatitis C, and follow-up phylogenetic testing. All participants who test positive for HIV or hepatitis C will be referred for counseling and treatment. HIV care and treatment will take place at multiple local centers offering these services.
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.
Exclusion Criteria:
*Participants will be classified as at moderate risk for IPV if they report 1) history of IPV during their lifetime either from a current or past partner; and/or 2) fear of IPV if they participate in the study.
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.
All participants in this arm will be offered assisted partner services (APS) which involves outreach to sexual partners and to individuals with whom they use injection drugs. When partners are contacted they are offered HIV and HCV testing. There is no comparison arm.
Behavioral: Assisted Partner Services
Contact tracing for sexual and drug-sharing partners to notify about exposure to HIV and offer HIV and hepatitis C testing with linkage to care and partner services for those who test positive.
Sexual partners tested
Numbers of sexual partners tested for HIV and HCV per index participant
Time frame: 4 years
Injecting partners tested
Numbers of injecting partners tested for HIV and HCV per index participant
Time frame: 4 years
Partners diagnosed with HIV and HCV
Number of partners newly diagnosed with HIV and HCV infection per index case
Time frame: 4 years
HIV-infected partners linked to HIV care
Percentage of HIV-infected partners linked to HIV care
Time frame: 4 years
HCV-infected partners linked to HCV care
Percentage of HCV-infected partners linked to HCV care
Time frame: 4 years
Index participants linked to HIV and HCV care
Percentage of index participants linked to HIV and HCV care
Time frame: 4 years
Plan to share: Yes — The proposed studies will include the following data: self-reported demographic and behavioral data, medical/sexual histories, HIV/HCV test results, and HIV/HCV genetic sequences. To facilitate the data sharing process, we will consider the need for data sharing in the study design, creation of informed consent documents, and the structure of data collection. Release of completed viral gene sequences (on NCBI Genbank) shall occur during the project, if appropriate, or at the end of the project, consistent with normal scientific practices.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 5-10 years
Ran from Feb 2018 to primary completion in Feb 2022, 48 months.
Of 642 non-industry interventional studies with no phase under Acquired Immunodeficiency Syndrome, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 45. This study's 48 months is above that.
Counting every sponsor, half of 648 studies reached it within 29 months; a quarter within 17 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome →