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Acceptability and Feasibility of Unsupervised HIV Self-Testing Among Networks of Men

Acceptability and Feasibility of Unsupervised HIV Self-Testing Among Networks of Men:Tanzania STEP (Self-Testing Education and Promotion) Project

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03891407
Acronym
STEP
Enrollment
500
Registered
2019-03-27
Start date
2019-06-01
Completion date
2019-09-01
Last updated
2020-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hiv, HIV/AIDS, HIV Infections

Brief summary

The purpose of this study is to recruit and train men to promote HIV self-testing to their network members in their camps and examine the efficacy of a peer-led HIV self-testing intervention on the uptake of HIV testing among men.

Detailed description

The research is the first evaluation of an unsupervised HIV self-testing strategy in Tanzania focusing on networks of heterosexual men. The reasons for focusing on heterosexual men is because heterosexual contact is the primary mode of HIV transmission in Tanzania and data from our previous trial indicate that 97% of the male camp members are heterosexual. Moreover it will be the first intervention to engage male peer leaders to promote HIV self-testing in their social networks in Tanzania. We will build on previous work our research team has conducted to identify 'camps' or local venues where young men socialize with elected leaders and members pay membership dues. Our previous intervention has proven successful to recruit and train leaders from camps to serve as community health leaders in their respective camps, with the goal of changing social norms related to HIV and gender-based violence. A novel approach to the proposed research is that we will leverage the work we have conducted within camps with social networks of men to test the acceptability and feasibility of oral fluid-based HIV self-testing and confirmatory blood-based HIV testing within existing networks of men that we know we can access through stable social venues. We will recruit male camp leaders to train them about HIV self-testing and instruct them to return to their camps and engage their male peers by informing them about HIV self-testing for prior to our research team offering participants the opportunity to self-test.

Interventions

DIAGNOSTIC_TESTSelf-Testing Education and Promotion

Camp members will receive the Self-Testing Education and Promotion (STEP locally referred to as Mate Yako Afya Yako) intervention and will receive HIV-counseling and oral HIV self-testing kits.

Sponsors

University of South Carolina
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

Peer-led recruitment strategy.

Intervention model description

Participants who agree to self-test will receive pretest counseling and a 10 minute demonstration, including a video in addition to verbal instructions, of how to use an oral self-test kit from a trained HIV counselor. After counseling, participants will receive 2 oral fluid self-test kits to conduct the self-test at home or in a private location during the next 3 months, a phone number to call in case they need assistance when performing the self-test at home, and a location where to return the used self-test kits and collect more test kits throughout the study period. Upon returning the used self-test kits after every 3 months, participants will be able to share their self-test result with the counselor. Participants will also be asked at each pick-up time to demonstrate they can use the kit to ensure participants continue to receive correct self-test results throughout the study period.

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Participant is at least 18 years old * Has been member of the camp for at least 3 months * Visits camp at least once a week * Intends to live in Dar es Salaam for next 6 months * Has not had suicidal thoughts in the past * Willing to give contact information of self and relative or friend

Exclusion criteria

* Does not meet all inclusion criteria * Unable to participate due to psychological disturbance, cognitive impairment or threatening behavior

Design outcomes

Primary

MeasureTime frameDescription
Number of HIV self-testing kits distributed in the past 3 Months3 monthsCamp members' use of the HIV self-testing kits will be evaluated at 3 months

Secondary

MeasureTime frameDescription
Number of camp members who self-report HIV self-testing in the past 3 months3 monthsCamp members will self-report HIV self-testing at 3 Months

Countries

Tanzania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026