Reducing stigma and promoting HIV wellness/mental health of sexual and gender minorities: a novel group-based cognitive behavioural therapy program in Nigeria
| ISRCTN | ISRCTN95309635 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95309635 |
| Secondary identifying numbers | 988 |
- Submission date
- 19/02/2024
- Registration date
- 23/02/2024
- Last edited
- 19/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
High levels of stigma due to identifying as a sexual or gender minority (SGM) and living with HIV are increasingly documented in the African setting, and often manifest as internalized stigma (self-stigma). Such stigmas, especially when they are multiple and compounding, impede psychosocial wellbeing as well as HIV prevention and care. Yet there are few, if any, interventions specifically focused on reducing intersecting internalized stigmas tested in Africa. In this study, the researchers will develop and evaluate a novel, group-based cognitive behavioural therapy (CBT) intervention for the MSM and TGW populations.
Who can participate?
Men who have sex with men (MSM) and transgender women (TGW) 18 years of age or older and at risk for or living with HIV in Lagos, Nigeria.
What does the study involve?
Participants are randomly allocated to either the immediate intervention or the delayed intervention group. The intervention comprises four weekly in-person group sessions facilitated by community health workers. The comparison group (i.e., the delayed intervention group) were made aware of the HIV and other services available through partner implementing organizations (e.g., HIV and STI prevention and treatment services). Surveys are carried out before and after the intervention and at a 3-month follow-up (immediate group only).
What are the possible benefits and risks of participating?
Participants benefit from the group sessions, specifically the opportunity to learn and talk about stigma, HIV services, being a sexual and gender minority in Nigeria, and having support from peers and community health workers.
The main risks posed to participants from the study and intervention procedures are psychological distress and breach of confidentiality. Psychological distress could arise from participating in the group sessions and surveys since they touch upon enacted and internalized stigma, depression and anxiety, HIV risk, living in the HIV, and experiences of violence. Psychological distress could also arise from breaches of confidentiality, particularly given the stigmatized and even criminalized nature of identities and behaviours in question in the country context. While breach of confidentiality is unlikely given protections in place, any potential breach is concerning particularly given same-sex behaviour is criminalized in Nigeria, as well as the stigmatized nature of both same-sex behaviour and HIV.
Where is the study run from?
Population Council (USA). The study is conducted in Lagos, Nigeria.
When is the study starting and how long is it expected to run for?
October 2021 to October 2023
Who is funding the study?
Elton John AIDS Foundation (USA)
Who is the main contact?
1. Dr Waimar Tun, wtun@popcouncil.org
2. Dr Julie Pulerwitz, jpulerwitz@popcouncil.org
Contact information
Public, Scientific, Principal Investigator
1015 15th St NW Fl 5
Washington
20005-2644
United States of America
| Phone | +1 (0)2409450638 |
|---|---|
| wtun@popcouncil.org |
Study information
| Study design | Prospective delayed randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Prevention, Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Evaluation of an internalized stigma reduction intervention for men who have sex with men, and transgender women, in Lagos, Nigeria via a prospective delayed group randomized controlled trial |
| Study objectives | The intervention will result in greater decreased internalized stigma related to being a sexual/gender minority, and related to living with HIV, among individuals randomized to the immediate vs delayed arm. |
| Ethics approval(s) |
Approved 15/02/2022, Population Council Institutional Review Board (1230 York Avenue, New York, 10065, United States of America; +1 (0)917 685 7660; ngontarz@popcouncil.org), ref: 988 |
| Health condition(s) or problem(s) studied | Prevention of mental health disorders (depression, anxiety) and increased uptake of HIV prevention and treatment services |
| Intervention | After recruitment, from separate listings of MSM and transgender women (TGW) enrolled participants, an investigator used a random numbers table and assigned individuals from each list to an intervention group (either the immediate intervention or the delayed intervention group); there were separate groups for MSM or TGW (given different experiences and social networks). Within 10 days of completion of the baseline survey, research assistants called participants to inform them of their randomization assignment. Group-based affirmative cognitive behavioral therapy: The intervention comprises four weekly in-person group sessions facilitated by community health workers. The evaluation design is a delayed intervention group randomized controlled trial, with pre-post surveys plus 3-month follow-up (immediate group only), as well as qualitative research with participants and program staff. The comparison group (i.e., the delayed intervention group) were made aware of the HIV and other services available through partner implementing organizations (e.g., HIV and STI prevention and treatment services). |
| Intervention type | Behavioural |
| Primary outcome measure | Internalized stigma related to being a sexual/gender minority and living with HIV (among those individuals living with HIV), measured using an adaptation of the Internalized AIDS-Related Stigma Scale (IA-RSS) at baseline and three additional points (approximately 1 month after baseline, 2 months after baseline, and 3 months after baseline) |
| Secondary outcome measures | Measured at baseline and three additional points (approximately 1 month after baseline, 2 months after baseline, and 3 months after baseline): 1. Depression measured using the Patient Health Questionnaire-8 (PHQ-8) 2. Anxiety measured using the General Anxiety Disorder-7 (GAD-7), such as ‘trouble relaxing’ and ‘not being able to control or stop worrying’ in the last 2 weeks 3. Coping was measured using the 4-item Brief Coping Scale 4. Uptake of pre-exposure prophylaxis and antiretroviral therapy (among participants living with HIV). Among those with HIV, adherence was defined as reporting “No days” to the question “During the past 3 days, on how many days have you missed all your pills?”. Antiretroviral treatment self-efficacy was assessed based on seven items from a validated scale (HIV-Adherence Self-Efficacy Scale with last month as the reference period. |
| Overall study start date | 01/10/2021 |
| Completion date | 31/10/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Male |
| Target number of participants | 300 |
| Total final enrolment | 240 |
| Key inclusion criteria | 1. 18 years or older 2. Assigned male at birth 3. [Among MSM subgroup] Had sex with a biological man in the last year; [Among Transgender women subgroup] Identify as a woman 4. Willing to participate in all four sessions of the intervention 5. Willing to participate in the study 6. Residing in Lagos State for the next 1 year |
| Key exclusion criteria | 1. Do not agree to participate in either the group sessions or study surveys 2. Planning to move out of Lagos State within the next one year 3. Currently participating in any other stigma reduction intervention 4. Not providing consent to participate in the intervention and study 5. Not providing contact information for follow-up |
| Date of first enrolment | 26/04/2022 |
| Date of final enrolment | 29/09/2022 |
Locations
Countries of recruitment
- Nigeria
Study participating centre
Lagos
100001
Nigeria
Sponsor information
Research organisation
1 Dag Hammarskjold Plz.
New York
10017
United States of America
| Phone | +1 (0)212 339 0500 |
|---|---|
| ngontarz@popcouncil.org | |
| Website | https://popcouncil.org/ |
"ROR" |
https://ror.org/03zjj0p70 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Elton John AIDS Foundation, Inc., EJAF
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Stored in publicly available repository |
| Publication and dissemination plan | Planned presentations at conferences and publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The dataset generated during the study will be stored in a publicly available repository (https://dataverse.harvard.edu/dataverse/popcouncil). The type of data stored – quantitative de-identified data from the multiple rounds of survey. The process for requesting access (if non-publicly available): Although it will be made available on DataVerse, the researchers require anyone interested in the data to contact one of the two contact investigators (Julie Pulerwitz or Waimar Tun) for permission to use the data. Interested persons must state their affiliation, qualifications, intended purpose, and how they will use the data. Given the sensitive nature of the topic in this environment, the researchers use stringent measures before making the data available. Dates of availability: 23 February 2024 Whether consent from participants was required and obtained: Yes Comments on data anonymization: Data has been stripped of any identifiers. Added 19/03/2024: Link to dataset: https://doi.org/10.7910/DVN/SG5XLP |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Dataset | 18/03/2024 | 19/03/2024 | No | No |
Editorial Notes
19/03/2024: Dataset added.
19/02/2024: Study's existence confirmed by the Population Council Institutional Review Board.
