Addressing Psychosocial Needs and HIV Risk in Indian MSM
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Tamil Nadu
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Chennai, Tamil Nadu, Inde
- Tuberculosis Research Centre
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, États-Unis, 02215
- Fenway Community Health
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: HIV/STI voluntary counseling and testing
Participants enrolled in the control arm will receive study assessments only.
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Expérimental: 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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Acquisition of STIs - Number of Participants That Acquired STIs
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Steven A. Safren, PhD, Massachusetts General Hospital, Boston, Massachusetts, United States
- Chercheur principal: Beena E. Thomas, PhD, Tuberculosis Research Centre, Chennai, India
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 5R21MH085314-02 (Subvention/contrat des NIH des États-Unis)
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