Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men

August 9, 2023 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1509

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kenya
      • Siaya, Kenya
        • Impact Research Development Organization

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult (18 years or older)
  • Male
  • Working as a fisherman or fishing-related occupation
  • Willing and able to provide informed consent for participation
  • Not participating in another research study related to HIV testing, treatment and/or prevention

Exclusion Criteria:

  • Younger than 18 years of age
  • Female
  • Included in another intervention study on HIV/AIDS
  • Inadequate cognitive and/or hearing capacity to complete planned study procedures, at the discretion of the study team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Promoter training, multiple self-test kits, and incentives
Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks.
Behavioral: Provision of multiple self-tests
Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
Other: Small monetary incentives
Use of small incentive voucher (~$5) to encourage linkage to confirmatory testing.
Behavioral: Use of SMS/text reminders to motivate adherence to ART or PrEP
Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.
No Intervention: Short training and referral for testing
Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-reported HIV testing
Time Frame: Up to 3 months
Proportion of participants who self-report HIV testing (yes/no) within the past 3 months, measured at 3-month follow-up.
Up to 3 months
Linkage to care or prevention
Time Frame: Up to 3 months

For HIV-positive participants (care): the proportion of participants who obtained confirmatory HIV testing (yes/no), 3-months following self-reported HIV testing AND the proportion of participants who had an HIV clinic visit (yes/no), 3-months following confirmatory HIV testing.

For HIV-negative participants (prevention): the proportion of participants who obtained confirmatory HIV testing (yes/no) 3-months following self-reported testing AND the proportion of participants who were evaluated for PrEP (yes/no), 3-months following confirmatory HIV testing.
Up to 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Linkage to ART or to PrEP
Time Frame: Up to 3 months

ART: Proportion of HIV-positive participants who initiate ART prescription (yes/no), 3-months following confirmatory testing and eligibility screening.

PrEP: Proportion of PrEP-eligible HIV-negative participants who initiate PrEP prescription (yes/no), 3-months following confirmatory testing and eligibility screening.
Up to 3 months
Adherence to ART or PrEP
Time Frame: Up to 6 months

ART: Proportion of HIV-positive participants who attain viral suppression (HIV RNA <400 c/mL), 6 months following ART initiation.

PrEP: proportion of PrEP-taking HIV-negative participants who are adherent to PrEP (TFV levels of >= 1500 ng/mL) at 6 months following PrEP initiation.
Up to 6 months
HIV testing after 3 months
Time Frame: 3 to 6 months
Confirmatory HIV testing uptake 3 to 6 months after intervention start
3 to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Mental Health (NIMH)
University of Pennsylvania
Duke University
Kenya Medical Research Institute
Impact Research & Development Organization

Investigators

  • Principal Investigator: Harsha Thirumurthy, PhD, University of Pennsylvania
  • Principal Investigator: Carol S Camlin, MPH, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Actual)

April 26, 2023

Study Completion (Actual)

April 26, 2023

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

August 9, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-28205
  • 1R01MH120176 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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