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

Primary Purpose

HIV Infections, HIV/AIDS, Hiv

Status
Completed
Phase
Phase 1
Locations
Tanzania
Study Type
Interventional
Intervention
Self-Testing Education and Promotion
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Tandale Community

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HIV Self-testing Group

Non-intervention Group

Arm Description

Camp members will receive information about HIV self-testing from peer educators who will be nominated by you and other camp members in your camp. Camp members in the STEP project will receive pretest counseling and a 10 minute demonstration. They will receive 1 oral fluid HIV self-test kit to conduct the self-test at home or in a private location during the next 1 month and a phone number to call in case you need assistance when performing the self-test at home. They will also receive information about the nearest HIV Care and Treatment Center where they can seek a confirmatory HIV test and start HIV treatment in the event of a positive self-test result.

Camp members will be encouraged to seek HIV testing at the clinics.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 26, 2019
Last Updated
November 20, 2020
Sponsor
University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT03891407
Brief Title
Acceptability and Feasibility of Unsupervised HIV Self-Testing Among Networks of Men
Acronym
STEP
Official Title
Acceptability and Feasibility of Unsupervised HIV Self-Testing Among Networks of Men:Tanzania STEP (Self-Testing Education and Promotion) Project
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
September 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV/AIDS, Hiv

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
Peer-led recruitment strategy.
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIV Self-testing Group
Arm Type
Experimental
Arm Description
Camp members will receive information about HIV self-testing from peer educators who will be nominated by you and other camp members in your camp. Camp members in the STEP project will receive pretest counseling and a 10 minute demonstration. They will receive 1 oral fluid HIV self-test kit to conduct the self-test at home or in a private location during the next 1 month and a phone number to call in case you need assistance when performing the self-test at home. They will also receive information about the nearest HIV Care and Treatment Center where they can seek a confirmatory HIV test and start HIV treatment in the event of a positive self-test result.
Arm Title
Non-intervention Group
Arm Type
No Intervention
Arm Description
Camp members will be encouraged to seek HIV testing at the clinics.
Intervention Type
Diagnostic Test
Intervention Name(s)
Self-Testing Education and Promotion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of HIV self-testing kits distributed in the past 3 Months
Description
Camp members' use of the HIV self-testing kits will be evaluated at 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of camp members who self-report HIV self-testing in the past 3 months
Description
Camp members will self-report HIV self-testing at 3 Months
Time Frame
3 months

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male members of participating camps.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Tandale Community
City
Dar Es Salaam
Country
Tanzania

12. IPD Sharing Statement

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

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