NCT04108078

Promoting Reductions in Intersectional StigMa (PRISM) - GHANA

Completed NA Last updated 6 March 2023

What this trial tests

NA trial testing Health Policy Plus (HP+) in HIV in 549 participants. Completed in 31 December 2022.

Timeline

1 October 2020

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	549
Start date	1 October 2020
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across Ghana

Drugs / interventions tested

• Health Policy Plus (HP+)
• Many Men Many Voices (3MV)
• HIV Education, Empathy and Empowerment (HIVE3)

Conditions studied

• HIV — all drugs for HIV →
• Stigma — all drugs for Stigma →

Sponsor

Yale University

Who can join

18 and older, any sex, with HIV or Stigma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

HIV prevalence among men with have sex with men (MSM) in Ghana is at least eight times higher than that of the general population (2%). MSM in Ghana face high levels of stigma due to HIV status (actual or perceived), same-sex behavior, and gender non-conformity. These stigmas are documented barriers to HIV prevention and treatment. In our preliminary work in Ghana (N=137), one-third of MSM had never been tested for HIV. This study is a randomized controlled trial to evaluate the feasibility, acceptability and estimate effect size of a multi-component, multi-level (organizational, interpersonal, and intrapersonal-level) intersectional stigma-reduction intervention to increase HIV testing frequency among MSM in Ghana where HIV, same-sex behavior and gender non-conformity are highly stigmatized. To date, stigma-reduction interventions in Ghana have focused on uni-level targets (e.g., health care facilities (HCFs)) and addressed one type of stigma (e.g., HIV), without engaging the intersectional character of the multiple stigmas that MSM encounter.

Our specific aims are:

1. to evaluate the feasibility and acceptability of a novel multi-component, multi-level intervention to address intersectional stigma.
2. to estimate effect size of the intervention for scale up to a definitive efficacy trial.

Our primary endpoint are:

For MSM: HIV testing, intervention feasibility and acceptability For HCFs: intervention feasibility, acceptability and appropriateness

Our secondary endpoints are:

MSM: Intersectional stigma reduction HCF: Intersectional stigma reduction

This study will combine three theory-based interventions that were previously implemented separately in Ghana for reducing stigma at HCF-level, increasing HIV testing at the peer group-level, and increasing peer social support at the individual-level. Convergence Framework will be used for combining interventions. The ADAPT-ITT framework guides our approach to enhancing the interventions' content on intersectional stigma. To achieve these aims a systematic adaptation that will be used to refine the individually developed HCF, peer- and individual-level interventions to produce a comprehensive multi-level intersectional stigma reduction intervention.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Multi-level intersectional stigma reduction intervention to increase HIV testing among men who have sex with men in Ghana: Protocol for a cluster randomized controlled trial.
   Nelson LE, Nyblade L, Torpey K, Logie CH, et al · · 2021 · cited 32× · PMID 34843529 · DOI 10.1371/journal.pone.0259324
2. Using a mixed-methods approach to adapt an HIV stigma reduction to address intersectional stigma faced by men who have sex with men in Ghana.
   Nyblade L, Stockton MA, Saalim K, Rabiu Abu-Ba'are G, et al · · 2022 · cited 31× · PMID 35818873 · DOI 10.1002/jia2.25908