Lafiya HIV Self-testing Study Protocol

Adaptation and Feasibility of Many Men Many Voices (3MV), an HIV Prevention Intervention to Reduce Intersectional Stigma and Increase HIVST Among YSMM Residing in Ghanaian Slums - A Clustered Pre-post Pilot Trial Protocol

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.

Study Overview

• Status: Active, not recruiting
• Conditions: HIV Prevention and Care
• Intervention / Treatment: Behavioral: LAFIYA

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ghana
  • Accra, Ghana
    • University of Ghana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All participants; Participants will be young sexual minority men (YSMM) and providers from healthcare institutions working with YSMM.	Behavioral: LAFIYA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number of HIV tests	We are going to collect the total number of HIV tests performed by all participants and report the mean change in number.	Baseline to 3 months
Mean change in the Basic Needs Satisfaction Scale.	The Basic Needs Satisfaction scale is a 9 question scale that asks participants general questions about experiences of feeling free within their community while identifying as YSMM. The outcome measure will analyze changes in average scores over time. The Basic Needs Satisfaction Scale is scored on a scale ranging from 1 to 10, where 1 represents the lowest possible level of basic needs satisfaction, and 10 represents the highest	Baseline to 3 months
Percentage of participants to report resilience/bouncing back after hard times.	Participants will be provided with a 6 question survey that inquires into a percentage change in their level of resilience. Each question inquires into their ability to bounce back or cope with challenges, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.	Baseline to 3 months
Percentage of participants that reported enacted stigma.	Participants will be provided with a 10 question survey that inquires into the rate at which they experienced unfair treatment by others. Each question will inquire into experiences of unfair treatment, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated for an overall percent score.	Baseline to 3 months
Percentage of participants that reported vicarious stigma.	Participants will be provided with a 10 question survey that inquires into the percentage rate at which they have heard stories about other YSMM stigma experiences. Each question inquires whether they have heard stories of other YSMM experiencing stigma, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.	Baseline to 3 months
Percentage of participants that reported perceived stigma.	Participants will be provided with a 10 question survey that inquires into the level of agreement or disagreement on perceived stigma. Each question inquires whether they agree or disagree with perceived stigma, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.	Baseline to 3 months
Percentage in participants that reported internalized stigma.	Participants will be provided with a 10 question survey that inquires into the percentage change in internalized stigma. Each question inquires into their experience of internalized stigma, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.	Baseline to 3 months
Percentage of participants that reported stigma for involving in same sex relations.	Participants will be provided with a 10 question survey that inquires into the frequency at which they encounter stigma from engaging in same-sex relations. Each question inquires into their experiences of stigma from engaging in same-sex relationships, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.	Baseline to 3 months
Percentage of participants that reported stigma from being gender non-conforming.	Participants will be provided with a 10 question survey that inquires into the frequency at which they encounter stigma due to their feminine mannerisms. Each question inquires into their experiences of stigma from being gender non-conforming, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.	Baseline to 3 months
Healthcare climate	Participants will be provided with a 6 question survey that inquires into the frequency at which they encounter negative health provider attitudes. Each question inquires into their experiences when dealing with health providers, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.	Baseline to 3 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Yale University; George Washington University; University of Ghana; Fogarty International Center of the National Institute of Health

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: January 25, 2024
• First Submitted That Met QC Criteria: January 25, 2024
• First Posted (Actual): February 2, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00008385; R01TW012671 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No