An interventional study of LAFIYA in HIV Prevention and Care, sponsored by University of Rochester. Withdrawn at 1 site in Ghana. Open to male participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University of Rochester · Not applicable, Interventional, and Prevention
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.
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Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
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Exclusion Criteria:
Participants will be young gay, bisexual and all other men who have sex men (YGBMSM) and providers from healthcare institutions working with (YGBMSM) who will receive the LAFIYA intervention.
Behavioral: LAFIYA
Control arm for comparison who will receive the intervention after the intervention group
Behavioral: LAFIYA
The Lafiya intervention is a comprehensive program designed to address the intersectional stigma and discrimination challenges faced by marginalized communities, particularly among Gay, Bisexual, and other Men who have Sex with Men (GBMSM). It aims to enhance HIV prevention, care, and treatment outcomes, with a focus on increasing HIV self-testing (HIVST) uptake among these key populations in Ghanaian urban slum settings.
Change in HIV testing.
We are going to collect the total number of HIV tests performed by all participants and report the mean change in numbers.
Time frame: Baseline to 9 months
Change in PrEP Adherence.
We will collect the total number of PrEP uptake and report the mean change in adherence ( mean change in urine tenofovir levels).
Time frame: Baseline to 9 months
Change in ART Adherence
We will assess changes in ART adherence among participants receiving HIV treatment, reporting mean changes in ART adherence (measured by HIV RNA levels).
Time frame: Baseline to 9 months
Change in Treatment Self-Efficacy.
We will assess changes in treatment self-efficacy among participants receiving HIV treatment, reporting mean changes in treatment self-efficacy scores. The scale will inquire into the experiences of treatment-related behaviors related to adhering to treatment plans, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage change of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated for an overall percentage.
Time frame: Baseline to 9 months
Percentage change in HIV stigmatizing attitudes.
Using the HIV stigmatizing scale, participants will be provided with an 18-question survey that measures mean changes in HIV stigmatizing attitudes before and after the intervention.Each question will inquire into experiences of stigmatizing attitudes from others, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage change of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated for an overall percent.
Time frame: Baseline to 9 months
Percentage change in reported sexual behavior stigma.
Using the sexual behavior stigma scale, participants will be provided with a 13-question survey that measures the mean changes in perceived, anticipated, and enacted sexual behavior stigma.Each question inquires whether they agree or disagree with perceived, anticipated, and enacted sexual behavior stigma, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage change of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Time frame: Baseline to 9 months
Percentage change in gender nonconformity stigma
Using the Gender Nonconformity Stigma Scale, participants will be presented with a 10-item survey designed to assess attitudes towards gender nonconformity. This survey will measure the mean changes in perceptions of feminine mannerisms and their associated stigma.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 change of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Time frame: Baseline to 9 months
Percentage change in PrEP-related stigma
Using the Youth PrEP-related Stigma Scale, participants will be provided with a 14-item survey that measures the mean changes in perceptions of PrEP-related, including misconceptions, fears, and judgments surrounding its use. Each question inquires into their experiences of PrEP-related Stigma, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage change of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Time frame: Baseline to 9 months
Neighborhood stigma
Participants will be provided with a 15-question survey that inquires into the rate at which they experienced unfair treatment within their neighborhood. 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 change of participants who responded yes to receiving unfair treatment in their neighborhood. The average percentage across all questions is calculated for an overall percent score.
Time frame: Baseline to 9 months
Mean change in the Basic Needs Satisfaction
The Basic Needs Satisfaction scale is a 6-question scale that asks participants general questions about experiences of feeling free within their community while identifying as YGMSM. 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.
Time frame: Baseline to 9 months
Percentage of participants that reported healthcare climate stigma.
Participants will be provided with a 15-question survey that inquires into the rate at which they experienced unfair treatment within the healthcare setting. Each question will inquire into experiences of unfair treatment, with responses categorized on a Likert scale ranging from strongly agree to disagree strongly. The survey results are then analyzed by calculating the percentage change of participants who responded affirmatively to unfair treatment they experience. The average percentage across all questions is calculated for an overall percent score.
Time frame: Baseline to 9 months
Percentage of participants that reported Brief Resilience
The Brief Resilience Scale is a 6-question survey that inquires into the level of resilience of participants. The scale includes statements that assess individuals' ability to bounce back and adapt positively to challenges and setbacks. 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 change of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Time frame: Baseline to 9 months
Changes in Healthcare facility Intersectional stigma and discrimination.
Using the adapted LGBTQ and Healthcare facility HIV stigma scales from Promoting Reductions in Intersectional StigMa (PRISM), Participants will be provided with a 22-item survey that measures changes in stigmatizing attitudes by health workers related to HIV stigma and gender non-conforming stigma. Each question inquires into their experience of intersectional stigma and discrimination, with responses categorized as "yes" or "no." The survey results are then analyzed by calculating the percentage change of participants who responded affirmatively (yes) to each question. The average percentage across all questions is calculated to arrive at an overall percent score.
Time frame: Baseline to 9 months
Plan to share: Undecided — It may not be shared because of the stigma and discrimination facing LGBTQ-plus persons and known providers for the population in Ghana.
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