Clinical trial NCT06238323: Lafiya HIV Self-testing Study Protocol
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Prevention and Care
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: University of Ghana
name: George Washington University
name: Yale University
name: Fogarty International Center of the National Institute of Health
First posted: 2024-02-02
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in percentage of participants that reported the intervention as acceptable
timeFrame: Baseline to 3 months
measure: Change in percentage of participants that reported the intervention as appropriate
timeFrame: Baseline to 3 months
measure: Change in percentage of participants that reported the intervention as feasible.
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Change in the number of HIV tests
timeFrame: Baseline to 3 months
measure: Mean change in the Basic Needs Satisfaction Scale.
timeFrame: Baseline to 3 months
measure: Percentage of participants to report resilience/bouncing back after hard times.
timeFrame: Baseline to 3 months
measure: Percentage of participants that reported enacted stigma.
timeFrame: Baseline to 3 months
measure: Percentage of participants that reported vicarious stigma.
timeFrame: Baseline to 3 months
measure: Percentage of participants that reported perceived stigma.
timeFrame: Baseline to 3 months
measure: Percentage in participants that reported internalized stigma.
timeFrame: Baseline to 3 months
measure: Percentage of participants that reported stigma for involving in same sex relations.
timeFrame: Baseline to 3 months
measure: Percentage of participants that reported stigma from being gender non-conforming.
timeFrame: Baseline to 3 months
measure: Healthcare climate
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: University of Ghana
Study officials:
References: