Lafiya HIV Self-testing Study Protocol

NCT06238323 | Recruiting

• 2 other identifiers: STUDY00008385R01TW012671
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to address low testing and related issues such as stigma, low-risk perception, and concerns about confidentiality affecting testing. To overcome these challenges, the study proposes to adapt the Many Men Many Voices (3MV) into a modified version called LAFIYA to tackle intersectional stigma and improve HIVST among young sexual minority men in Ghana.

Conditions

HIV Prevention and Care

Outcome Measures

Primary Outcomes (3)

• Change in percentage of participants that reported the intervention as acceptable

  Participants will be provided with a survey that inquires if HIVST meets their approval, meets their needs, and if they welcome the use of HIVST. Participants will answer yes or no, and reported is the change in the percentage of participants that answered yes to each question.

  Baseline to 3 months

• Change in percentage of participants that reported the intervention as appropriate

  Participants will be provided with a survey that inquires if HIVST seems reasonable, if HIVST seems like a good match, and if HIVST seems applicable. Participants will answer yes or no, and reported is the change in the percentage of participants that answered yes to each question.

  Baseline to 3 months

• Change in percentage of participants that reported the intervention as feasible.

  Participants will be provided with a survey that inquires if HIVST seems easy to use, if HIVST seems challenging, and if HIVST seems practical. Participants will answer yes or no, and reported is the change in the percentage of participants that answered yes to each question.

  Baseline to 3 months

Secondary Outcomes (10)

• Change in the number of HIV tests

  Baseline to 3 months

• Mean change in the Basic Needs Satisfaction Scale.

  Baseline to 3 months

• Percentage of participants to report resilience/bouncing back after hard times.

  Baseline to 3 months

• Percentage of participants that reported enacted stigma.

  Baseline to 3 months

• Percentage of participants that reported vicarious stigma.

  Baseline to 3 months

Study Arms (1)

All participants

EXPERIMENTAL

Participants will be young sexual minority men (YSMM) and providers from healthcare institutions working with YSMM.

Behavioral: LAFIYA

Interventions

LAFIYA BEHAVIORAL

LAFIYA will be a modified version of the Many Men Many Voices (3MV) targeted at addressing reducing stigma and increasing HIV self-testing uptake among young sexual minority men. LAFIYA will be developed into a comprehensive intervention manual for a large-scale trial using the ADAPTT-IT framework.

All participants

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• YSMM: To be eligible to participate in the interview, the person must be between 18 to 25 years old, have no experience using unassisted HIVST kits, do not know their HIV status or tested negative, currently identifies as cis-gender man, and have had sex with another man within six months before engaging with the recruitment team and must reside within a slum community in the Greater Accra Metropolitan area.
• Providers: To be eligible to participate in the interview, the person must have experience providing sexual health services such as HIV testing, counseling, and linkage to prevention and care services for at least one year. Must reside within the Greater Accra Metropolitan area and have worked with YSMM on HIV prevention and care.

You may not qualify if:

• YSMM: Those who fall under 18 years or above 25 years will be excluded from the study. YSMM who have experience with unassisted HIVST kits, know their HIV status, or tested positive for HIV will be excluded from the study. YSMM who do not identify as cis-gender man and have not had sex with another man within six months before engaging with the recruitment team will be excluded from the study. YSMM who do not reside within a slum community in the Greater Accra Metropolitan area will be excluded from the study.
• Providers: Persons who do not have experience providing services such as HIV testing, counseling, and linkage to prevention and care services for at least one year will be excluded from the study. Providers not residing within the Greater Accra Metropolitan area and have not worked with YSMM on HIV prevention and care will be excluded.

Sponsors & Collaborators

• University of Rochester: lead
• University of Ghana: collaborator
• George Washington University: collaborator
• Yale University: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

University of Ghana

Accra, Ghana

RECRUITING

Central Study Contacts

Gamji R Abu-Ba'are, PhD

CONTACT

16077595760; GamjiRabiu_Abubaare@URMC.Rochester.edu

Kwasi Torpey, PhD

CONTACT

+233302213820; Ktorpey@ug.edu.gh

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: February 1, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)