Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04108078 |
| Other study ID # |
2000025917 |
| Secondary ID |
1R01NR019009-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2020 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Yale University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
STUDY DESCRIPTION OVERVIEW. Our goal in this study is to determine the feasibility,
acceptability and preliminary estimate of effect size of a multi- level intersectional
stigma-reduction intervention on HIV testing among MSM in Ghana. This study has two phases: a
formative phase and a test phase. The eight-step ADAPT-ITT framework will guide our approach
to enhancing the interventions' content to address intersectional stigma and combine the
three separate interventions into one multi- level approach. Aim 1 will encompass steps 1-7,
leading to the combined multi-level intervention adapted to deepen intersectional stigma
content and step 8 in which the study team will conduct a waitlist-controlled RCT of the
adapted intervention for feasibility and acceptability. In Aim 2, data generated in the RCT
will be used to estimate the effect size of the multi-level intervention on HIV testing among
MSM (primary outcome) and intersectional stigma reduction (secondary outcome) among the MSM
and HCF staff. In deciding on the RCT with wait-list control was considered with other
designs such as factorial designs and a classic RCT design with time and attention-matched
controls. It was determined that the RCT with wait-list control was superior to the other
designs because our study is premised on the need for combined interventions. Since it is not
intended yet to seek to isolate which component of the intervention had the greatest effect
on our outcomes, a factorial design was not scientifically justified for our proposed study.
Additionally, ethical and budgetary considerations informed our decision to forgo using a
structurally equivalent control in favor of a wait-list control for the intervention given
the evidence of each interventions' efficacy for reducing stigma among HCF staff and
improving HIV testing among MSM.
FORMATIVE PHASE STEP 1: ASSESS Focus group discussions (FGDs) and in-depth interviews (IDIs)
will be conducted with MSM and HCF staff to inform the adaptation of the three existing
interventions to deepen intersectional stigma content and their integration with each other
to address intersectional stigma at multiple levels. FGDs were chosen because of their
demonstrated suitability in studies of sexual health and to capitalize on the spontaneous
conversational interaction that occurs in groups. This re-creation of the social dynamic with
the HCF staff and MSM is critical to the understanding of intersectional stigma from the
social organization of these two groups. There are also plans to conduct a limited set of
individual interviews to examine more in-depth, topics that elicit intimate personal accounts
that may not be suitable for sharing in groups. For example, MSM PLHIV are targeted for IDIs
to gain insight into whether and how intersectional stigma experiences influenced their pre-
diagnosis prevention behaviors, access to prevention services, timing of HIV testing and
linkage to care post-diagnosis.
Qualitatively, the following will be investigated:
1. the drivers and manifestations of HIV, same-sex and gender non-conforming stigmas
(intersectional stigma) within HCFs and MSM peer groups
2. how these intersecting stigmas undermine HIV testing
3. perspectives on strategies for reducing intersectional stigma within HCFs and among MSM
peer groups. This information will guide to what degree and how these stigmas are
addressed within the intervention.
In each study city (Accra and Kumasi), 2-4 FGDs will take place in each with HCF staff and
MSM, as well as IDIs with HP+ trainers from the pilot phase (n=10) and MSM with HIV (n=8).
The purpose and expectations of involvement in the study will be explained to prospective
participants.
STEP 2: DECIDE Guided by the formative research results, the team will meet to discuss what
specific intervention activities should be modified to address intersectional stigma. An
updated scoping review of research literature to identify innovative evidence-based options
to enhance focus on intersecting stigmas, with special attention to technology and social
media options. This will include a review of the current intervention activities and
discussion of how they can be refined to address intersecting stigmas. In consultation with
our civil society partners, the team will then incorporate these changes into the curriculum,
identify gaps/errors in logic and make corrections in preparation to conduct a workshop of
the intervention with key reference groups.
STEP 3: ADMINISTER After initial modifications, a facilitated simulation workshop of the
intervention activities with a combined group of HP+ HCF staff (n=4) and client trainers
(n=2) who delivered HP+ in other health facilities in Ghana and MSM (n=8) who received the
original 3MV and HIVE3 interventions will take place. Then, the team will conduct a joint
workshop session because it is consistent with the concept that the intervention must retain
relevance to MSM at all points along the HIV testing pathway, including in the HCF and among
their peer-groups. The next step will be produce a revised combined version of the original
intervention manuals before the workshop and conduct a series of facilitated simulation
exercises with role-play over a 4-day period. Participants will work through each of the
intervention levels, focusing on the intersectional stigma content and reviewing our approach
to linking the different levels and creating opportunities for safe contact between HCF staff
and MSM.
STEP 4: PRODUCE Based on the feedback from the simulation workshop participants and our
observations of their engagement with the activities, the study team will determine what
content and approaches to incorporate into the adapted intervention manual and which content
and processes to edit or forego. In our decision-making process, the study team will give
priority consideration to maintaining components that have the highest consistency with
scientific literature on intersectional stigma, local cultural relevance, and likelihood to
be fun/enjoyable-key requisites for successful intervention uptake.
STEP 5: TOPIC The study team will engage topic experts to review the adapted manual and
provide feedback on its congruence with the original intervention and local sociocultural
relevance. A copy of the adapted, combined multi-level intervention manual will be provided
to the principal investigators of the original separate level interventions. Ghanaian MSM who
lead PORSH and YAHR (our two civil-society organization partners that work with Ghanaian MSM)
will give feedback that is key to the local cultural relevance and intervention
implementation.
STEP 6: INTEGRATE In this step, feedback provided by the topic experts will be taken and
summarized in a report that will be distributed to the entire investigative team, including
our key local partners. The feedback will be discussed to develop follow-up clarifying
questions to the topic experts, as necessary, before making final revisions to the
multi-level intervention manual.
STEP 7: TRAIN The study team will also produce a training manual to standardize training and
permit future replication of the intervention in other settings. This will provide
comprehensive training to study staff whose roles are dedicated to delivering the
intervention. In addition, the development of multi-faceted training will take place to
facilitate comprehension and retention of training concepts, using strategies that Drs.
Nyblade and Nelson has successfully deployed in other HIV prevention research projects. This
will include conducting a joint (including teams from both cities) rehearsal of the protocol
prior to implementation in the RCT with HCF staff and MSM who are not part of the trial.
RANDOMIZATION PROCEDURES Matched pairing of study facilities: the study will assign four HCFs
in each study city to intervention and control groups by matching the size of HCF facility
staff censure. In every city, the plan is to first stratify four clinics into a pair of two
larger clinics and a pair of two smaller clinics, and then randomly assign one larger and one
smaller clinic to either arm. HCFs will be assigned using a randomization sequence created in
SAS 9.4 with a 1:1 allocation using random block sizes of four by an independent research
assistant. A separate research assistant will open the sealed envelopes to identify group
assignment immediately after completion of baseline data collection.
Random assignment of MSM participants. Consented/eligible MSM will be randomized in a 1:1
ratio to intervention versus control arm. A block-randomization approach using a random
numbers generator to assign participants to the study arms will be employed, which ensures
that the number of participants assigned to the intervention arm in each of the two study
cities (or blocks) is approximately equal to the control arm.
