Addressing Psychosocial Needs and HIV Risk in Indian MSM
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Forente stater, 02215
- Fenway Community Health
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Tamil Nadu
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Chennai, Tamil Nadu, India
- Tuberculosis Research Centre
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: HIV/STI voluntary counseling and testing
Participants enrolled in the control arm will receive study assessments only.
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Eksperimentell: Behavioral intervention
Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months.
This intervention focuses on psychosocial concerns and HIV risk for MSM in India.
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The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months.
The overall focus is on psychosocial concerns and HIV risk.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant
Tidsramme: up to 6 months
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We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.
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up to 6 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Acquisition of STIs - Number of Participants That Acquired STIs
Tidsramme: 6 months
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We will test for locally relevant STIs at baseline and 6 months.
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6 months
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Changes in Psychosocial Mediators
Tidsramme: up to 6 months
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We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.
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up to 6 months
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Steven A. Safren, PhD, Massachusetts General Hospital, Boston, Massachusetts, United States
- Hovedetterforsker: Beena E. Thomas, PhD, Tuberculosis Research Centre, Chennai, India
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 5R21MH085314-02 (U.S. NIH-stipend/kontrakt)
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