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

HIV Infections Clinical Trial

— STEP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03891407
• Other study ID #: Pro00072005
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 1, 2019
• Est. completion date: September 1, 2019

Study information

• Verified date: November 2020
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 1, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hiv
• HIV Infections
• HIV/AIDS

Intervention

Diagnostic Test:
• Self-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.

Locations

Country	Name	City	State
Tanzania	Tandale Community	Dar Es Salaam

Sponsors (1)

Lead Sponsor	Collaborator
University of South Carolina

Country where clinical trial is conducted

Tanzania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of HIV self-testing kits distributed in the past 3 Months	Camp members' use of the HIV self-testing kits will be evaluated at 3 months	3 months
Secondary	Number of camp members who self-report HIV self-testing in the past 3 months	Camp members will self-report HIV self-testing at 3 Months	3 months