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

NCT03891407 | Completed Phase 1 FDA Device

• 1 other identifier: Pro00072005
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; HIV/AIDS; Hiv

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of camp members who self-report HIV self-testing in the past 3 months

  3 months

Study Arms (2)

HIV Self-testing Group

EXPERIMENTAL

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.

Diagnostic Test: Self-Testing Education and Promotion

Non-intervention Group

NO INTERVENTION

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

Interventions

Self-Testing Education and Promotion DIAGNOSTIC_TEST

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.

HIV Self-testing Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male members of participating camps.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to participate due to psychological disturbance, cognitive impairment or threatening behavior

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

Tandale Community

Dar es Salaam, Tanzania

Location

MeSH Terms

Conditions

HIV Infections; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Peer-led recruitment strategy.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Coordinator for Donaldson Conserve

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: March 27, 2019
• Study Start: June 1, 2019
• Primary Completion: July 30, 2019
• Study Completion: September 1, 2019
• Last Updated: November 25, 2020

Record last verified: 2020-11

Locations

TA (1)