Lafiya HIV-status Neutral Study - Protocol

NCT ID: NCT06312514

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-20

Study Completion Date

2028-08-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Prevention and Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

intervention and waitlist control groups
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

None (Open Label)

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Arm

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.

Group Type EXPERIMENTAL

LAFIYA

Intervention Type BEHAVIORAL

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.

Waitlist control group.

Control arm for comparison who will receive the intervention after the intervention group

Group Type EXPERIMENTAL

LAFIYA

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Ghana

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gamji Rabiu Abu-Ba'are

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Ghana

Accra, , Ghana

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Ghana

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Gamji R Abu-Ba'are, PhD

Role: CONTACT

16077595760

Kwasi Torpey, PhD

Role: CONTACT

+233302213820

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 38854081 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01NR021170

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00008615

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

HIV Prevention for African American Teens
NCT00279799 COMPLETED PHASE3