Trial Outcomes & Findings for Addressing Psychosocial Needs and HIV Risk in Indian MSM (NCT NCT01266122)
NCT ID: NCT01266122
Last Updated: 2015-06-01
Results Overview
We will examine sexual risk taking among the sample using self-report (interviewer administered) measures.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
up to 6 months
Results posted on
2015-06-01
Participant Flow
Participant milestones
| Measure |
HIV/STI Voluntary Counseling and Testing
Participants enrolled in the control arm will receive study assessments only.
|
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.
Behavioral intervention: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
48
|
|
Overall Study
COMPLETED
|
42
|
42
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
HIV/STI Voluntary Counseling and Testing
Participants enrolled in the control arm will receive study assessments only.
|
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.
Behavioral intervention: 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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
Baseline Characteristics
Addressing Psychosocial Needs and HIV Risk in Indian MSM
Baseline characteristics by cohort
| Measure |
HIV/STI Voluntary Counseling and Testing
n=48 Participants
Participants enrolled in the control arm will receive study assessments only.
|
Behavioral Intervention
n=48 Participants
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.
Behavioral intervention: 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.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.7 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
28.4 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
29 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 6 monthsWe will examine sexual risk taking among the sample using self-report (interviewer administered) measures.
Outcome measures
| Measure |
HIV/STI Voluntary Counseling and Testing
n=48 Participants
Participants enrolled in the control arm will receive study assessments only.
|
Behavioral Intervention
n=48 Participants
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.
Behavioral intervention: 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.
|
|---|---|---|
|
Changes in HIV Risk Taking Behavior - Number of Condomless Sex Acts Per Participant
|
7.58 number of unprotected sex acts
Standard Deviation 1.36
|
3.69 number of unprotected sex acts
Standard Deviation .73
|
SECONDARY outcome
Timeframe: 6 monthsWe will test for locally relevant STIs at baseline and 6 months.
Outcome measures
| Measure |
HIV/STI Voluntary Counseling and Testing
n=48 Participants
Participants enrolled in the control arm will receive study assessments only.
|
Behavioral Intervention
n=48 Participants
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.
Behavioral intervention: 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.
|
|---|---|---|
|
Acquisition of STIs - Number of Participants That Acquired STIs
|
14 participants
|
8 participants
|
SECONDARY outcome
Timeframe: up to 6 monthsWe will examine the degree to which hypothesized mediators change differentially across the experimental and control arms.
Outcome measures
Outcome data not reported
Adverse Events
HIV/STI Voluntary Counseling and Testing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Behavioral Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Steven Safren
Behavioral Medicine Service, Massachusetts General Hospital
Phone: 617-724-0817
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place