An interventional study of Text Messaging and Peer Navigation in HIV/AIDS, Adherence, Medication and Drug Use, sponsored by University of Washington. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-05.
Sponsored by University of Washington · Not applicable, Interventional, and Prevention
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable.
Despite increasing knowledge about and use of PrEP nationally, HIV continues to have disproportionate impact among cisgender men and transgender persons who have sex with men and transgender persons (MSM/TG), with methamphetamine (meth)-users being at particularly high risk. Despite apparent high levels of PrEP knowledge and exceptional insurance and medication coverage, few meth-users in Western WA have enrolled in local PrEP programs. The investigators' preliminary work with meth-using MSM/TG has identified both traditional barriers to PrEP and barriers specific for meth users, including competing priorities (e.g., getting high); lack of regularity in daily schedules leading to difficulties complying with appointments and medication adherence; and concomitant wellness and social concerns, notably depression and meth-related stigma. Additional work is needed to develop new strategies to increase PrEP uptake and support persistence and adherence among meth-using MSM/TG. Building on their preliminary work, the investigators will pilot text messaging and peer navigation interventions to support PrEP use among meth-using MSM/TG with potential to be cost-effective, scalable, and easily adaptable. The first, peer navigation, has been studied in ARV treatment and has been proposed for PrEP. The second, text messaging, has been shown to increase ARV and PrEP adherence.
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Exclusion Criteria:
Participants in this group will receive the standard of care for PrEP follow-up and no additional research interventions.
Participants in this group will receive the text messaging intervention.
Behavioral: Text Messaging
Participants in this group will receive the peer navigator intervention.
Behavioral: Peer Navigation
Participants in this group will receive both the text messaging and peer navigation interventions.
Behavioral: Text Messaging · Behavioral: Peer Navigation
The text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts.
The peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals.
Acceptability of Text Messaging
Self-reported likelihood to recommend the text messaging intervention, via survey response, among those who received the text messaging intervention (may have been in the Standard of care group or the Peer Navigation group). Only participants who received the text messaging intervention are included in the analysis group.
Time frame: 6 months
Acceptability of Peer Navigation
Self-reported likelihood to recommend the peer navigation intervention, via survey response, among those who were assigned to the peer navigation group. Only participants who received the peer navigation intervention are included in the analysis group.
Time frame: 6 months
PrEP Persistence
Persistence on PrEP comparing standard of care or text messaging vs peer navigation, as measured by whether the participant had returned to the clinic at 6 months follow up their DBS card collection.
Time frame: 6 months
PrEP Adherence
PrEP adherence measured in dried blood spots comparing standard of care/text messaging vs peer navigation, as measured by the detection of tenofovir-diphosphate (TFV-DP) in DBS collected 6 months after study enrollment.
Time frame: 6 months
| Milestone | Standard of Care/Text Messaging | Peer Navigation |
|---|---|---|
| Started | 12 | 9 |
| Completed | 5 | 6 |
| Not completed | 7 | 3 |
Self-reported likelihood to recommend the text messaging intervention, via survey response, among those who received the text messaging intervention (may have been in the Standard of care group or the Peer Navigation group). Only participants who received the text messaging intervention are included in the analysis group.
| Participants | Standard of Care/Text Messaging | Peer Navigation |
|---|---|---|
| Very Unlikely to Recommend | 0 | 0 |
| Unlikely to Recommend | 0 | 1 |
| Neither Unlikely nor Likely to Recommend | 1 | 0 |
| Likely to Recommend | 0 | 0 |
| Very Likely to Recommend | 1 | 1 |
| Data Missing (e.g. Survey not completed, question left blank) | 1 | 1 |
Persistence on PrEP comparing standard of care or text messaging vs peer navigation, as measured by whether the participant had returned to the clinic at 6 months follow up their DBS card collection.
| Participants | Standard of Care/Text Messaging | Peer Navigation |
|---|---|---|
| PrEP Persistence | 4 | 6 |
PrEP adherence measured in dried blood spots comparing standard of care/text messaging vs peer navigation, as measured by the detection of tenofovir-diphosphate (TFV-DP) in DBS collected 6 months after study enrollment.
| Participants | Standard of Care/Text Messaging | Peer Navigation |
|---|---|---|
| BLQ | 0 | 1 |
| <2 doses/week | 1 | 1 |
| 2-3 doses/week | 1 | 1 |
| 4-6 doses/week | 0 | 2 |
| 7 doses/week | 2 | 1 |
| No DBS collected | 8 | 3 |
Self-reported likelihood to recommend the peer navigation intervention, via survey response, among those who were assigned to the peer navigation group. Only participants who received the peer navigation intervention are included in the analysis group.
| Participants | Peer Navigation |
|---|---|
| Very Unlikely to Recommend | 0 |
| Unlikely to Recommend | 0 |
| Neither Unlikely nor Likely to Recommend | 0 |
| Likely to Recommend | 1 |
| Very Likely to Recommend | 3 |
| Data Missing (e.g. Survey not completed or question left blank) | 5 |
Collected over 6 months of follow up for each participant, or until loss to follow up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard of Care/Text Messaging | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Peer Navigation | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Continuous(years) | Standard of Care/Text Messaging | Peer Navigation | Total |
|---|---|---|---|
| Median | 36 (28 to 40) | 33 (29 to 40) | 35 (29 to 40) |
| Sex/Gender, Customized(participants) | Standard of Care/Text Messaging | Peer Navigation | Total |
|---|---|---|---|
| cisgender man | 10 | 8 | 18 |
| transgender female | 1 | 1 | 2 |
| Non-binary/genderqueer | 1 | 0 | 1 |
| Race/Ethnicity, Customized(participants) | Standard of Care/Text Messaging | Peer Navigation | Total |
|---|---|---|---|
| American Indian or Alaskan Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 3 |
| Multiracial | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| White | 10 | 3 | 13 |
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