Evaluation of the Journeys of Shared Resilience group program among Black sexual minority men in Washington, DC

ISRCTN ISRCTN14264476
DOI https://doi.org/10.1186/ISRCTN14264476
Submission date
08/10/2024
Registration date
09/10/2024
Last edited
09/10/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Stigmas due to identifying as a sexual minority, being at risk for/living with HIV, and due to race, are common and often manifest as internalized stigmas (self-stigmas). 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 and promoting shared resilience. In this study, the researchers will evaluate Journeys of Shared Resilience - a novel, group-based program that positively affirms identities and builds cognitive behavioral therapy (CBT) skills among Black sexual minority men living in the Washington, DC area.

Who can participate?
Black sexual minority men ages 18 years or older, who are living or working in the Washington, DC area.

What does the study involve?
Participants will attend four weekly in-person group Journeys of Shared Resilience sessions facilitated by community health workers. Surveys will be carried out before and 3 months after the program to assess its acceptability, appropriateness, feasibility, and effectiveness. Additional qualitative in-depth / group interviews will be completed with a subset of participants, as well as other stakeholders.

What are the possible benefits and risks of participating?
Participants may benefit from the group sessions, specifically the opportunity to learn and talk about stigma, information about available health services, and 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 with HIV, and experiences of violence. Psychological distress could also arise from breaches of confidentiality, particularly given the often stigmatized nature of the identities in question. While a breach of confidentiality is unlikely given protections in place, any potential breach would be concerning.

Where is the study run from?
Us Helping Us, Washington, DC (USA)

When is the study starting and how long is it expected to run for?
June 2023 to May 2025

Who is funding the study?
National Institutes of Health via the Washington DC CFAR (Center for AIDS Research) (USA)

Who is the main contact?
1. Dr Julie Pulerwitz, jpulerwitz@popcouncil.org
2. Dr DeMarc Hickson, dhickson@uhupil.org

Contact information

Dr Julie Pulerwitz
Scientific, Principal Investigator

1015 15th st nw
Office 529
Washington, DC
20005
United States of America

ORCiD logoORCID ID 0000-0001-5177-1508
Phone +1 (0)202 237 9400
Email jpulerwitz@popcouncil.org
Dr DeMarc Hickson
Principal Investigator

Us Helping Us
3636 Georgia Avenue NW
Washington DC
20010
United States of America

Phone +1 (0)202 446 1092
Email dhickson@uhupil.org
Dr Ann Gottert
Public, Scientific

1015 15th St NW
Washington, DC
20005
United States of America

Phone +1 (0)202 237 9400
Email agottert@popcouncil.org

Study information

Study designPre-post comparison, complemented by qualitative research
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Community, Other
Study typeOther, Prevention
Participant information sheet Not available in web format. Please use contact details to request a participant information sheet.
Scientific titleEvaluation of Journeys of Shared Resilience: a group program to address intersectional stigmas, and support shared resiliency and HIV wellness, among Black sexual minority men in Washington, DC
Study acronymJSR Eval
Study objectivesThe program will result in significant declines in internalized stigma and depression, and improvements in community connectedness.
Ethics approval(s)

Approved 10/07/2023, Population Council Institutional Review Board (1230 York Avenue, New York, 10065, United States of America; +1 (0)917 685 7660; ngontarz@popcouncil.org), ref: 1023

Health condition(s) or problem(s) studiedPrevention of internalized stigma and depression and promotion of community connectedness among Black sexual minority men
InterventionGroup program based on affirmative cognitive behavioral therapy, with four curriculum-based sessions, each ~2.5 hours long, facilitated by trained community health workers. The program will be evaluated by pre- and 3-month post-surveys, complemented by qualitative research.
Intervention typeBehavioural
Primary outcome measureIntersectional internalized stigma, as measured by several scales (including a nine-item scale adapted from scale developed by Dr Lisa Bowleg and colleagues), at baseline and 3-month post assessments
Secondary outcome measures1. Acceptability of program, measured using survey responses to a set of 11 satisfaction questions at the end of the final program session, plus themes elucidated from post-assessment in-depth/group interviews
2. Depression measured by the Patient Health Questionnaire-8 at baseline and 3-month post assessments
3. Community connectedness measured by a nine-item Community Connectedness scale, at baseline and 3-month post assessments
4. Exploratory outcome: self-reported current PrEP use at baseline and 3-month post assessments
Overall study start date01/06/2023
Completion date31/05/2025

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit99 Years
SexMale
Target number of participants60
Key inclusion criteria1. Lives or works in the city of DC or neighboring Prince George’s County, Maryland
2. Age 18 years or older
3. Self-reported sexual orientation is gay/sexual minority man/MSM
4. Self-reported sex assigned at birth is male
5. Self-reported race is Black/African American
6. Has ready access to a personal computer, tablet, or smartphone with a connection to the internet
7. Speaks English well enough to read English study-related documents and participate in the intervention, conducted in English
8. Willing and able to participate in the intervention/study
Key exclusion criteria1. Participated in previous formative research related to the program
2. Do not agree to participate in either the group sessions or study surveys
Date of first enrolment15/10/2024
Date of final enrolment28/02/2025

Locations

Countries of recruitment

  • United States of America

Study participating centre

Us Helping Us
3636 Georgia Ave NW
Washington
20010
United States of America

Sponsor information

Population Council
Research organisation

One Dag Hammarskjold Plaza
2nd Floor
New York, NY
10017
United States of America

Phone +1 (0)212 339 0500
Email pubinfo@popcouncil.org
Website http://www.popcouncil.org/
ROR logo "ROR" https://ror.org/03zjj0p70
Us Helping Us People Into Living
Charity

3636 Georgia Avenue NW
Washington, DC
20010
United States of America

Phone +1 (0)202 446 1092
Email dhickson@uhupil.org
Website http://www.ushelpingus.org
ROR logo "ROR" https://ror.org/05w0kdr76

Funders

Funder type

Government

National Institutes of Health (NIAID) via Washington DC Center for AIDS Research

No information available

Results and Publications

Intention to publish date01/03/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planPlanned presentations at conferences and publication in a high-impact peer-reviewed journal.
IPD sharing planThe 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 each survey round.

The process for requesting access (if non-publicly available): Although it will be made available on DataVerse, given the sensitive nature of the topic, the researchers will require anyone interested in the data to contact the investigators for permission to use the data.

Editorial Notes

09/10/2024: Study's existence confirmed by the Population Council Institutional Review Board.