Trial Outcomes & Findings for Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk (NCT NCT03386110)

NCT ID: NCT03386110

Last Updated: 2021-08-19

Results Overview

The self-reported number of illicit drug use instances (not including marijuana) in the past 30 days

Recruitment status

COMPLETED

Study phase

Target enrollment

100 participants

Primary outcome timeframe

Baseline, 3-month follow-up; 6-month follow-up

Results posted on

2021-08-19

Participant Flow

We used an index participant approach to recruit couples. Online recruitment included advertisements on websites and geosocial networking apps for gay, bisexual, trans, and queer people seeking out sexual partners. Also, staff attended bars, nightclubs, and other social events for these populations in the NYC metro area to screen. Through June 2019, eligible index participants were contacted by phone to complete a study specific screener. This was converted to an online survey in July 2019.

Participant milestones

Participant milestones
Measure	Couples Health Project (CHP) Participants who received the intervention condition, CHP	Education Participants who received the attention-matched Education control
Overall Study STARTED	56	44
Overall Study COMPLETED	41	38
Overall Study NOT COMPLETED	15	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Couples Health Project: Couples-based Intervention to Reduce Drug Use and HIV Transmission Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Couples Health Project (CHP) n=56 Participants Participants who received the intervention condition, CHP	Education n=44 Participants Participants who received the attention-matched Education control	Total n=100 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=5 Participants	44 Participants n=7 Participants	100 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.7 years STANDARD_DEVIATION 6.17 • n=5 Participants	28.05 years STANDARD_DEVIATION 6.10 • n=7 Participants	28.41 years STANDARD_DEVIATION 6.12 • 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	56 Participants n=5 Participants	44 Participants n=7 Participants	100 Participants n=5 Participants
Race/Ethnicity, Customized Race & Ethnicity · White/European	33 Participants n=5 Participants	25 Participants n=7 Participants	58 Participants n=5 Participants
Race/Ethnicity, Customized Race & Ethnicity · Black/African American	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Race & Ethnicity · Latino	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Race/Ethnicity, Customized Race & Ethnicity · Other	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	56 participants n=5 Participants	44 participants n=7 Participants	100 participants n=5 Participants
HIV Status HIV-negative	51 Participants n=5 Participants	39 Participants n=7 Participants	90 Participants n=5 Participants
HIV Status HIV-positive	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 3-month follow-up; 6-month follow-up

Population: Intent-to-treat population (assigned to either the CHP intervention or Education Control)

The self-reported number of illicit drug use instances (not including marijuana) in the past 30 days

Outcome measures

Outcome measures
Measure	Couples Health Project (CHP) n=56 Participants Participants who received the intervention condition, CHP	Education n=44 Participants Participants who received the attention-matched Education control
Illicit Drug Use Use at 6-month follow-up	1.17 Days (in the past 30 days) Standard Deviation 3.79	0.58 Days (in the past 30 days) Standard Deviation 1.24
Illicit Drug Use Use at Baseline	3.36 Days (in the past 30 days) Standard Deviation 8.46	0.84 Days (in the past 30 days) Standard Deviation 2.34
Illicit Drug Use Use at 3-month follow-up	3.13 Days (in the past 30 days) Standard Deviation 8.41	0.73 Days (in the past 30 days) Standard Deviation 1.37

PRIMARY outcome

Timeframe: 6 months

Population: Intent-to-treat population (assigned to either the CHP intervention or Education Control)

The self-reported number of events of condomless anal sex (CAS) with casual partners in the past 30 days

Outcome measures

Outcome measures
Measure	Couples Health Project (CHP) n=56 Participants Participants who received the intervention condition, CHP	Education n=44 Participants Participants who received the attention-matched Education control
Number of HIV Transmission Risk Events Events at Baseline	1.68 Events in the past 30 days Standard Deviation 2.78	1.68 Events in the past 30 days Standard Deviation 2.34
Number of HIV Transmission Risk Events Events at 3-month follow-up	2.13 Events in the past 30 days Standard Deviation 3.61	1.49 Events in the past 30 days Standard Deviation 3.70
Number of HIV Transmission Risk Events Events at 6-month follow-up	0.88 Events in the past 30 days Standard Deviation 1.66	1.05 Events in the past 30 days Standard Deviation 1.82

SECONDARY outcome

Timeframe: 6 months

Population: Intent-to-treat population (assigned to either the CHP intervention or Education Control)

The self-reported number of marijuana drug use instances in the past 30 days

Outcome measures

Outcome measures
Measure	Couples Health Project (CHP) n=56 Participants Participants who received the intervention condition, CHP	Education n=44 Participants Participants who received the attention-matched Education control
Marijuana Use Use at Baseline	9.61 days out of 30 Standard Deviation 11.93	7.02 days out of 30 Standard Deviation 10.24
Marijuana Use Use at 3-month follow-up	9.62 days out of 30 Standard Deviation 11.83	5.95 days out of 30 Standard Deviation 10.24
Marijuana Use Use at 6-month follow-up	10.00 days out of 30 Standard Deviation 12.43	7.89 days out of 30 Standard Deviation 11.75

Adverse Events

Couples Health Project (CHP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Education

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

Tyrel J. Starks

Hunter College

Phone: 212-206-7919

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place