Lafiya HIV-status Neutral Study - Protocol

NCT06312514 | Not Yet Recruiting

• 2 other identifiers: STUDY00008615R01NR021170
• Study Type: interventional
• Target: 880
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Prevention and Care

Keywords

HIV testing; PrEP; ART; MSM; Ghana; HIV Status-Neutral; Slums; young men

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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).

  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.

  Baseline to 9 months

Secondary Outcomes (9)

• Percentage change in HIV stigmatizing attitudes.

  Baseline to 9 months

• Percentage change in reported sexual behavior stigma.

  Baseline to 9 months

• Percentage change in gender nonconformity stigma

  Baseline to 9 months

• Percentage change in PrEP-related stigma

  Baseline to 9 months

• Neighborhood stigma

  Baseline to 9 months

Study Arms (2)

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.

Behavioral: LAFIYA

Waitlist control group.

EXPERIMENTAL

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

Behavioral: LAFIYA

Interventions

LAFIYA 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.

Intervention Arm; Waitlist control group.

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Nursing Research (NINR): collaborator
• University of Ghana: collaborator
• Yale University: collaborator

Study Sites (1)

University of Ghana

Accra, Ghana

Location

Related Publications (1)

• 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.

  PMID: 38854081 DERIVED

Central Study Contacts

Gamji R Abu-Ba'are, PhD

CONTACT

16077595760; GamjiRabiu_Abubaare@URMC.Rochester.edu

Kwasi Torpey, PhD

CONTACT

+233302213820; Ktorpey@ug.edu.gh

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label)
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: intervention and waitlist control groups

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 15, 2024
• Study Start: April 20, 2025
• Primary Completion (Estimated): August 29, 2028
• Study Completion (Estimated): August 29, 2028
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

GH (1)