Trial Outcomes & Findings for HIV/STI Prevention for Drug-Involved Couples (NCT NCT01285349)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

564 participants

Primary outcome timeframe

90 days

Results posted on

2019-01-14

Participant Flow

Participant milestones

Participant milestones
Measure	Couple Wellness Promotion 7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition. Couple Wellness Promotion :	Couple-based HIV Prevention 7-session couple-based HIV/STI risk reduction intervention (CSTI) Couple HIV/STI prevention intervention : Couple-based HIV prevention :	Individual HIV/STI Prevention 7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI. Individual HIV/STI prevention :
Overall Study STARTED	190	190	184
Overall Study COMPLETED	163	170	157
Overall Study NOT COMPLETED	27	20	27

Reasons for withdrawal

Reasons for withdrawal
Measure	Couple Wellness Promotion 7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition. Couple Wellness Promotion :	Couple-based HIV Prevention 7-session couple-based HIV/STI risk reduction intervention (CSTI) Couple HIV/STI prevention intervention : Couple-based HIV prevention :	Individual HIV/STI Prevention 7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI. Individual HIV/STI prevention :
Overall Study Lost to Follow-up	27	20	27

Baseline Characteristics

HIV/STI Prevention for Drug-Involved Couples

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Couple Wellness Promotion n=190 Participants 7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition. Couple Wellness Promotion :	Couple-based HIV Prevention n=190 Participants 7-session couple-based HIV/STI risk reduction intervention (CSTI) Couple HIV/STI prevention intervention : Couple-based HIV prevention :	Individual HIV/STI Prevention n=184 Participants 7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI. Individual HIV/STI prevention :	Total n=564 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	190 Participants n=99 Participants	190 Participants n=107 Participants	184 Participants n=206 Participants	564 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Age, Continuous	37.0 years STANDARD_DEVIATION 6.8 • n=99 Participants	36.1 years STANDARD_DEVIATION 7.4 • n=107 Participants	37.0 years STANDARD_DEVIATION 7.2 • n=206 Participants	36.5 years STANDARD_DEVIATION 7.1 • n=7 Participants
Sex: Female, Male Female	95 Participants n=99 Participants	95 Participants n=107 Participants	92 Participants n=206 Participants	282 Participants n=7 Participants
Sex: Female, Male Male	95 Participants n=99 Participants	95 Participants n=107 Participants	92 Participants n=206 Participants	282 Participants n=7 Participants
Region of Enrollment United States	190 participants n=99 Participants	190 participants n=107 Participants	184 participants n=206 Participants	564 participants n=7 Participants

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Outcome measures
Measure	Couple-Based Wellness Promotion n=163 Participants 7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition. Couple Wellness Promotion :	Couple-based HIV Prevention n=170 Participants 7-session couple-based HIV/STI risk reduction intervention (CSTI) Couple HIV/STI prevention intervention : Couple-based HIV prevention :	Individual HIV/STI Prevention n=163 Participants 7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI. Individual HIV/STI prevention :
Number of Unprotected Acts of Intercourse	19.7 # of unprotected sex acts at 12 months Standard Deviation 28.1	12.9 # of unprotected sex acts at 12 months Standard Deviation 19.2	18.2 # of unprotected sex acts at 12 months Standard Deviation 27.0

SECONDARY outcome

Timeframe: past 12 months

Outcome measures

Outcome measures
Measure	Couple-Based Wellness Promotion n=163 Participants 7-session couple-based stress reduction intervention (CSR) that serves as an attentional control condition. Couple Wellness Promotion :	Couple-based HIV Prevention n=170 Participants 7-session couple-based HIV/STI risk reduction intervention (CSTI) Couple HIV/STI prevention intervention : Couple-based HIV prevention :	Individual HIV/STI Prevention n=184 Participants 7-session individual HIV/STI intervention comparison condition (ISTI) provided to the index participant alone, which is identical in content to the CSTI. Individual HIV/STI prevention :
Number of Participants With Biologically Confirmed STIs (i.e., Chlamydia, Gonorrhea, and Trichomoniasis)	3 participants	3 participants	2 participants

Adverse Events

Couple Wellness Promotion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Couple-based HIV Prevention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Individual HIV/STI Prevention

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. Nabila El-Bassel

Social Intervention Group

Phone: 212-851-2391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place