Clinical trial NCT06312514: Lafiya HIV-status Neutral Study - Protocol
Official title: Status-neutral Community-based Multilevel Intervention to Address Intersectional Stigma and Discrimination, and Increase HIV Testing, PrEP, and ART Uptake Among YGBMSM in Ghanaian Slums: A Clustered Randomized Control Trial Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: HIV Prevention and Care
Keywords: HIV testing
PrEP
ART
MSM
Ghana
HIV Status-Neutral
Slums
young men
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: University of Ghana
name: Yale University
First posted: 2024-03-15
Enrollment: 880
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: intervention and waitlist control groups
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to adapt and evaluate the feasibility of "Lafiya," which means "Wellness" in Hausa, a multilevel intersectional stigma \& discrimination (ISD) and HIV testing intervention, to a status-neutral intervention to increase HIV testing, PrEP, and ART Uptake (HPART) among young gay, bisexual, and other men who have sex with men in Ghanaian slums. Specific objectives include, Assessing intersectional stigma and options for HPART implementation, Adapting Lafiya to a status-neutral intervention to address intersectional stigma and increase HPART uptake among YGBMSM, Test acceptance, feasibility, appropriateness, and preliminary efficacy of Lafiya to address intersectional stigma and increase HIVST uptake.


Eligibility criteria: Inclusion Criteria:

* YGBMSM FGD and IDI: To be eligible for FGD, the person must be between 18 to 25 years old, currently identify as a cis-gender man, have had sex with another man within 8 months before engaging with the recruitment team, and must reside within a slum community in the Accra metropolitan areas. To be eligible for IDIs, participants must self-disclose living with HIV.
* GBMSM civil society organizations FGD: The person must have experience providing GBMSM with HIV prevention and care services for at least one year. Must reside in the Accra metropolitan area.
* HCF staff FGDs: HCF staff are eligible to participate in the FGDs if employed at a study-participating facility.
* Anti-ISD Trained Nurses IDIs HCF staff are eligible to participate if they are trained in our previous interventions and have previously delivered them in a Ghanaian HCF.

Exclusion Criteria:

* YGBMSM FGD and IDI: Persons outside the age range of 18 to 25 years old, persons who do not identify as cis-gender men, persons who have not had sex with another man within 8 months before engaging with the recruitment team.
* GBMSM civil society organizations FGD: persons who do not have experience providing GBMSM with HIV prevention and care services for at least one year. Persons who do not reside within a slum community in the Accra metropolitan area (residence outside this area would be excluded).
* HCF staff FGDs: HCF staff are not eligible to participate in the FGDs if they are not employed at a study-participating facility.
* Anti-ISD Trained Nurses IDIs: HCF staff are not eligible to participate if they are not trained in our previous interventions and have not previously delivered them in a Ghanaian HCF.

Primary outcomes:
measure: Change in HIV testing.
timeFrame: Baseline to 9 months
measure: Change in PrEP Adherence.
timeFrame: Baseline to 9 months
measure: Change in ART Adherence
timeFrame: Baseline to 9 months
measure: Change in Treatment Self-Efficacy.
timeFrame: Baseline to 9 months
Secondary outcomes:
measure: Percentage change in HIV stigmatizing attitudes.
timeFrame: Baseline to 9 months
measure: Percentage change in reported sexual behavior stigma.
timeFrame: Baseline to 9 months
measure: Percentage change in gender nonconformity stigma
timeFrame: Baseline to 9 months
measure: Percentage change in PrEP-related stigma
timeFrame: Baseline to 9 months
measure: Neighborhood stigma
timeFrame: Baseline to 9 months
measure: Mean change in the Basic Needs Satisfaction
timeFrame: Baseline to 9 months
measure: Percentage of participants that reported healthcare climate stigma.
timeFrame: Baseline to 9 months
measure: Percentage of participants that reported Brief Resilience
timeFrame: Baseline to 9 months
measure: Changes in Healthcare facility Intersectional stigma and discrimination.
timeFrame: Baseline to 9 months
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: University of Ghana
Study officials:
References: