Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-31 @ 4:43 PM
Study NCT ID:
NCT04772469
Status:
COMPLETED
Last Update Posted:
2025-04-29
First Post:
2021-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
Sponsor:
University of California, San Francisco
Organization:
Study Overview
Official Title:
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized controlled trial to test a combination behavioral and biomedical interventions to improve the HIV prevention and care cascades in a population of mobile men in a high priority setting (fishermen in Kenya). The intervention strategy is to recruit and train highly socially-connected men to distribute HIV self-tests and provide linkage support to men in their close social networks. The study will determine whether this social network-based approach along with small financial incentives in the form of transport vouchers can increase men's self-testing, linkage to and uptake of ART and PrEP after self-testing, virologic suppression at 6 months (for those initiating ART) and PrEP adherence (for those initiating PrEP) at 6 months. The study includes a longitudinal qualitative and mixed methods (quantitative and qualitative assessments) to identify the pathways of intervention action, and understand how the social network-based approach with support for linkage affects testing and ART and PrEP uptake and retention in men.
Detailed Description:
In Aim 1, following the study pilot, community selection, and preparation the investigators will conduct a census/BMU registry verification in study communities to identify the population of men eligible for the study. The study will screen, recruit and enroll eligible men who give their informed consent to participate, then measure their close social networks identify network-central, highly-connected men ("promoters") and randomize their close social network (a cluster) to 1:1 intervention and control groups. Investigators will then conduct a baseline survey to collect socio demographic and baseline sexual behavior data among men in the close social networks. Following this baseline data collection, all promoters will be provided a training. Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration. Promoters in the control group will receive basic HIV education and training about the study, and will be given vouchers that can be exchanged for HIV tests (standard or free HIVST kits) at nearby health facilities. Using follow-up survey data, investigators will test the hypothesis that a higher rate of HIV testing will be observed after 3 months among men in networks that receive the intervention compared to control.
In Aim 2, investigators will test whether network-central promoters can enhance linkage to ART and PrEP after HIV testing among men in their close social networks. Promoters in the Aim 1 intervention group will be asked to distribute information and transport vouchers for ART or PrEP when distributing HIV self-tests to men in their close social networks. Investigators will use clinic data to test the primary hypothesis that the intervention will result in higher rates of linkage to ART or PrEP (confirmatory testing and ART referral for positives, and PrEP screening for negatives). Investigators also will test the hypothesis that higher ART and PrEP uptake will be observed within 3 months (+ about one month) in the intervention group.
In Aim 3, investigators will measure 6 month VL and 6 month tenofovir levels using viral load testing and a novel point of care PrEP adherence assay (an antibody-based assay permitting measurement of tenofovir levels in urine) in study sites, and test the hypothesis that higher rates of virologic suppression will be observed in HIV-infected men, and PrEP adherence in un-infected men, in the intervention group. Viral load measurements will be conducted by drawing additional venous blood during routine blood draws scheduled for MOH viral load monitoring (as well as additional draws during scheduled appointments for those occurring outside of the annual VL testing standard of care window). PrEP adherence will be measured utilizing the study urine assay at 6 months. HIV treatment adherence will measured through adherence assessment during 3 and 6 routine clinic visits.
Across all aims, investigators will assess the pathways of intervention action using qualitative and mixed methods. Investigators will identify the mechanisms of action, and barriers and facilitators of the social network and incentives intervention implementation, using qualitative and mixed methods quantitative and qualitative assessments embedded in Aims 1, 2 and 3. The data collection approach will include in-depth interviews with participants in both groups, key informant interviews with network-central promoters, and focus group discussions with study participants stratified by HIV status and study group. Data will be collected at baseline and three follow-up periods corresponding to the timing of quantitative outcome measurements in Aims 1 through 3.
In Aim 2, investigators will test whether network-central promoters can enhance linkage to ART and PrEP after HIV testing among men in their close social networks. Promoters in the Aim 1 intervention group will be asked to distribute information and transport vouchers for ART or PrEP when distributing HIV self-tests to men in their close social networks. Investigators will use clinic data to test the primary hypothesis that the intervention will result in higher rates of linkage to ART or PrEP (confirmatory testing and ART referral for positives, and PrEP screening for negatives). Investigators also will test the hypothesis that higher ART and PrEP uptake will be observed within 3 months (+ about one month) in the intervention group.
In Aim 3, investigators will measure 6 month VL and 6 month tenofovir levels using viral load testing and a novel point of care PrEP adherence assay (an antibody-based assay permitting measurement of tenofovir levels in urine) in study sites, and test the hypothesis that higher rates of virologic suppression will be observed in HIV-infected men, and PrEP adherence in un-infected men, in the intervention group. Viral load measurements will be conducted by drawing additional venous blood during routine blood draws scheduled for MOH viral load monitoring (as well as additional draws during scheduled appointments for those occurring outside of the annual VL testing standard of care window). PrEP adherence will be measured utilizing the study urine assay at 6 months. HIV treatment adherence will measured through adherence assessment during 3 and 6 routine clinic visits.
Across all aims, investigators will assess the pathways of intervention action using qualitative and mixed methods. Investigators will identify the mechanisms of action, and barriers and facilitators of the social network and incentives intervention implementation, using qualitative and mixed methods quantitative and qualitative assessments embedded in Aims 1, 2 and 3. The data collection approach will include in-depth interviews with participants in both groups, key informant interviews with network-central promoters, and focus group discussions with study participants stratified by HIV status and study group. Data will be collected at baseline and three follow-up periods corresponding to the timing of quantitative outcome measurements in Aims 1 through 3.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1R01MH120176 | NIH | None | https://reporter.nih.gov/quic… | View |