HIV Infections
Conditions
Brief summary
This randomized controlled trial evaluates the efficacy of couples HIV testing and counseling retesting. Eligible couples previously enrolled in NCT05000866 are invited to participate. Those who do are randomized to either couples HIV testing and counseling (CHTC) retesting or an individual HIV testing control. Follow-ups occur 3 and 6 months post intervention.
Detailed description
The purpose of this study is to evaluate the benefits associated with couples HIV testing and counseling (CHTC) resting. After their 12-month follow-up, those participants who remain in the same relationship they were in at the time of their baseline will be offered the opportunity to continue in the components proposed in this revision. Those who consent will be randomized to either complete a second session of CHTC or to a comparison condition in which both partners receive a routine individual HIV test. HIV positive partners in serodiscordant couples randomized to the control condition will receive information about anti-retroviral treatment adherence and U=U (undetectable = untransmissible). Given potential attrition and rates of relationship dissolution, we anticipate randomizing 200 couples (80% of the original sample). Follow-up assessments will be conducted 3 and 6 months after retesting (15 and 18 months after the participants' original baseline appointment).
Interventions
BEHAVIORALCouples HIV testing and counseling
Couples HIV testing follows a CDC published protocol for delivery of HIV testing to relationship partners. HIV test results are obtained from Oraquick (FDA approved for at home HIV testing)
BEHAVIORALIndividual HIV testing and counseling
Individual HIV testing and counseling uses a counseling protocol based on the standard of care for routine HIV pre- and post-test counseling. HIV test results are obtained from Oraquick (FDA approved for at home testing)
Sponsors
Hunter College of City University of New York
National Institute on Drug Abuse (NIDA)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Research assistants are not given access to information about study condition.
Intervention model description
Participants are randomized (with equal allocation) to either couples HIV testing and counseling retesting or an individual HIV testing control.
Eligibility
Sex/Gender
MALE
Age
17 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: 1. enrolled previously in the parent study DA050508 (NCT05000866). 2. in a relationship with the same main partner with whom they completed the baseline intervention session. 3. both partners in the couple must consent to continue with activities specified in this revision. 4. completion of the 12-month assessment associated with participation in the parent study prior to consenting to participate in activities specified under this revision. Exclusion: any of the following at the 12-month follow-up: 1. serious psychiatric symptoms; 2. current suicidal/homicidal ideation; 3. gross cognitive impairment 4. a history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of condomless anal sex acts with a casual partner in the absence of PrEP | 6 months | Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binge drinking | 6 months | Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview |
| pre-exposure prophylaxis (PrEP) uptake | 6 months | self-reported receipt of a PrEP-prescription |
| PrEP adherence | 6 months | taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments |
| Drug use Frequency | 6 months | Number of reported days of illicit drug use (amphetamines, cocaine/crack, gama hydroxybutyric acid (GHB), ketamine or ecstasy) reported on quarterly timeline follow-back assessments |
Countries
United States
Outcome results
None listed