- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01266122
Addressing Psychosocial Needs and HIV Risk in Indian MSM
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, Förenta staterna, 02215
- Fenway Community Health
-
-
-
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Tamil Nadu
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Chennai, Tamil Nadu, Indien
- Tuberculosis Research Centre
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: HIV/STI voluntary counseling and testing
Participants enrolled in the control arm will receive study assessments only.
|
|
Experimentell: 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.
|
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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant
Tidsram: up to 6 months
|
We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.
|
up to 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Acquisition of STIs - Number of Participants That Acquired STIs
Tidsram: 6 months
|
We will test for locally relevant STIs at baseline and 6 months.
|
6 months
|
Changes in Psychosocial Mediators
Tidsram: up to 6 months
|
We will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.
|
up to 6 months
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Steven A. Safren, PhD, Massachusetts General Hospital, Boston, Massachusetts, United States
- Huvudutredare: Beena E. Thomas, PhD, Tuberculosis Research Centre, Chennai, India
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 5R21MH085314-02 (U.S.S. NIH-anslag/kontrakt)
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