Clinical trial NCT01266122: Addressing Psychosocial Needs and HIV Risk in Indian MSM
Official title: Addressing Psychosocial Needs and HIV Risk in Indian MSM
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/STI Risk
HIV/STI Incidence
Keywords: HIV
Psychosocial problems
MSM
India
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Tuberculosis Research Centre, India
name: Fenway Community Health
First posted: 2010-12-24
Enrollment: 96
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will develop and pilot test a combined individual and group-level behavioral HIV prevention intervention for men who have sex with men (MSM) in Chennai, India, addressing HIV risk within the context of broader psychosocial issues, including self-acceptance, substance use and social support.

Detailed description: MSM in India are at increased risk for HIV in a stigmatizing environment that includes discrimination and violence. There is a need for evidence-based MSM HIV prevention interventions that address HIV risk in the context of these psychosocial issues. This study consists of formative qualitative work followed by the development and testing of a pilot behavioral HIV prevention intervention for MSM in Chennai, India. Study goals are to maximize intervention feasibility and acceptability, estimate an effect size for a power analysis, and prepare for a full-scale trial to follow.

PHASE 1-Intervention Development. This phase involved the collection of formative data through MSM focus groups and key informant interviews to develop a subsequent pilot behavioral intervention.

PHASE 2-Open Pilot. Following Phase 1, the team conducted an open-phase non-randomized pilot of the intervention. Enrollment involved a baseline assessment that included an interviewer-administered behavioral assessment and voluntary counseling and testing for HIV and the STIs, syphilis, gonorrhea and chlamydia. Eleven MSM in Chennai then completed 6 group sessions and 4 individual sessions over 3 months. A follow-up behavioral assessment was administered upon completion of all sessions, and 6 months after baseline participants were again administered the questionnaire and HIV/STI testing.

PHASE 3-Pilot Randomized Controlled Trial. The study is currently in Phase 3, and the data articulated in this registry is for Phase 3. We are now conducting a pilot randomized controlled trial (RCT) of the intervention among 6 "batches" of 8 MSM in each group (n=48). Comparison groups (n=48) will receive the same baseline assessment and voluntary HIV/STI counseling and testing as the intervention groups. Based on Phase 2 findings, the intervention groups will meet for 4 group sessions and 4 individual sessions. Those assigned to receive the comparison condition will not receive these sessions. Participants complete the assessments approximately 3 months after randomization, and again 3 months after that.

Eligibility criteria: Inclusion Criteria:

* Man who has had unprotected sex with another man in past 3 months
* Resident of Tamil Nadu state, India
* Identifies as Khothi or Double-decker

Exclusion Criteria:

* Does not identify as a man (i.e. Hijra/ Ali/Transgendered)
* Under age 18
* Unable to complete or understand informed consent procedures

Primary outcomes:
measure: Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant
timeFrame: up to 6 months
Secondary outcomes:
measure: Acquisition of STIs - Number of Participants That Acquired STIs
timeFrame: 6 months
measure: Changes in Psychosocial Mediators
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Fenway Community Health
state: Massachusetts
city: Chennai
country: India
facility: Tuberculosis Research Centre
state: Tamil Nadu
Study officials:
affiliation: Massachusetts General Hospital, Boston, Massachusetts, United States
name: Steven A. Safren, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tuberculosis Research Centre, Chennai, India
name: Beena E. Thomas, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Cleirigh C, Safren SA, Taylor SW, Goshe BM, Bedoya CA, Marquez SM, Boroughs MS, Shipherd JC. Cognitive Behavioral Therapy for Trauma and Self-Care (CBT-TSC) in Men Who have Sex with Men with a History of Childhood Sexual Abuse: A Randomized Controlled Trial. AIDS Behav. 2019 Sep;23(9):2421-2431. doi: 10.1007/s10461-019-02482-z.