HIV Prevention and CareNCT06312514
Lafiya HIV-status Neutral Study - Protocol
A study testing LAFIYA in people with HIV Prevention and Care, run by University of Rochester at 1 site in Ghana.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention and Care
- What is being tested?
- LAFIYA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGhana
- Study dates
- 20 Apr 2025to 29 Aug 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- HIV Prevention and Care
- Being tested
- LAFIYA
- Keywords
- HIV testing, PrEP, ART, MSM, Ghana, HIV Status-Neutral, Slums, young men
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LAFIYABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 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. Receives: Behavioral: LAFIYA |
| Waitlist control group. | Experimental | Control arm for comparison who will receive the intervention after the intervention group Receives: Behavioral: LAFIYA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: Baseline to 9 months
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start20 Apr 2025 (estimated)
- Primary completion29 Aug 2028 (estimated)
- Study completion29 Aug 2028 (estimated)
Why it stopped: terminated by the new administration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV Prevention and CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- intervention and waitlist control groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of Ghana, Yale University
- Responsible party
- Principal investigator, Gamji Rabiu Abu-Ba'are, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312514
- Sponsor's protocol ID
- STUDY00008615
- Other IDs
- R01NR021170
- Status last verified
- Feb 2025
- First submitted
- 7 Mar 2024
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It may not be shared because of the stigma and discrimination facing LGBTQ-plus persons and known providers for the population in Ghana.
Publications
Abu-Ba'are GR, Torpey K, Guure C, Nelson LE, Jeon S, McMahon J, Leblanc NM, Shamrock OW, Zigah EY, Apreku A, Dakpui HD, Agbemedu GRK, Boakye F, Adu P, Attisoe A, Adjaka G. 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. Res Sq [Preprint]. 2024 May 30:rs.3.rs-4486078. doi: 10.21203/rs.3.rs-4486078/v1.
PubMed 38854081
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06312514
- Acronym / sponsor ID
- STUDY00008615
- Conditions
- HIV Prevention and Care
- Keywords
- HIV testing, PrEP, ART, MSM, Ghana, HIV Status-Neutral, Slums, young men
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: terminated by the new administration
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of Ghana, Yale University
- Study start
- 20 Apr 2025 (estimated)
- Primary completion
- 29 Aug 2028 (estimated)
- Study completion
- 29 Aug 2028 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- intervention and waitlist control groups
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: LAFIYAParticipants 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. |
| Waitlist control group. | Experimental | Behavioral: LAFIYAControl arm for comparison who will receive the intervention after the intervention group |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LAFIYAThe 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. | Behavioural | Intervention Arm, Waitlist control group. |
Primary outcome
Change in HIV testing.
Time frame: Baseline to 9 months
We are going to collect the total number of HIV tests performed by all participants and report the mean change in numbers.
Change in PrEP Adherence.
Time frame: Baseline to 9 months
We will collect the total number of PrEP uptake and report the mean change in adherence ( mean change in urine tenofovir levels).
Change in ART Adherence
Time frame: Baseline to 9 months
We will assess changes in ART adherence among participants receiving HIV treatment, reporting mean changes in ART adherence (measured by HIV RNA levels).
Change in Treatment Self-Efficacy.
Time frame: Baseline to 9 months
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.
9 secondary outcomes
Percentage change in HIV stigmatizing attitudes.
Time frame: Baseline to 9 months
Percentage change in reported sexual behavior stigma.
Time frame: Baseline to 9 months
Percentage change in gender nonconformity stigma
Time frame: Baseline to 9 months
Percentage change in PrEP-related stigma
Time frame: Baseline to 9 months
Neighborhood stigma
Time frame: Baseline to 9 months
Mean change in the Basic Needs Satisfaction
Time frame: Baseline to 9 months
Percentage of participants that reported healthcare climate stigma.
Time frame: Baseline to 9 months
Percentage of participants that reported Brief Resilience
Time frame: Baseline to 9 months
Changes in Healthcare facility Intersectional stigma and discrimination.
Time frame: Baseline to 9 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Derived from this study: PubMed 38854081Abu-Ba'are GR, Torpey K, Guure C, Nelson LE, Jeon S, McMahon J, Leblanc NM, Shamrock OW, Zigah EY, Apreku A, Dakpui HD, Agbemedu GRK, Boakye F, Adu P, Attisoe A, Adjaka G. 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. Res Sq [Preprint]. 2024 May 30:rs.3.rs-4486078. doi: 10.21203/rs.3.rs-4486078/v1.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LAFIYA in people with HIV Prevention and Care, run by University of Rochester at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HIV testing. (time frame: Baseline to 9 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06312514, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.