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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of Michigan | OTHER |
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This study utilizes a randomized controlled trial design to evaluate the efficacy of two intervention components for couples HIV testing and counseling (CHTC): a communication skills training video and a substance use module. Participants are randomized in a full-factorial design to one of 4 conditions: CHTC as usual; CHTC + communication skills training videos; CHTC + substance use module; or CHTC plus both adjunct components.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHTC as usual | No Intervention | Participants complete the standard Couples HIV Testing and Counseling session (CHTC). | |
| CHTC and communications skills training video | Active Comparator | Participants complete the standard Couples HIV Testing and Counseling session and also watch a communication skills training video together. |
|
| CHTC and substance use module | Active Comparator | Participants complete the standard Couples HIV Testing and Counseling session and also complete a substance use module together. |
|
| CHTC, communications skills training and substance use module | Active Comparator | Participants complete the standard Couples HIV Testing and Counseling session and watch a communication skills training video and complete a substance use module together. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Communication skills training video | Behavioral | The communication skills training video component is designed to be self-delivered. Four couples are depicted in separate scenes discussing HIV testing, drug use, sexual agreements, and drug use during sex. Each scene is viewed twice. In the initial viewing, the couple in the video makes one or more communication errors. The scene is subsequently viewed a second time and the couple utilizes more effective communication skills, resulting in a more adaptive resolution. Each scene is introduced by a narrator who points out communication errors and orients viewers to skills utilized in adaptive versions of each scene. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug use frequency | Number of reported days of illicit drug use (amphetamines, cocaine/crack, GHB, ketamine or ecstasy) reported on quarterly timeline follow-back assessments | 12 months |
| Urine assay for drug use | Positive urine screen for drug use assessed bi-annually | 12 months |
| CAS with casual partners | Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments | 12 months |
| Bacterial STI's | Any chlamydia or gonorrhea diagnosis assessed bi-annually | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Binge drinking | Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview | 12 months |
| Syphilis infection | Reactive RPR test assessed bi-annually |
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Inclusion Criteria:
· Have a main partner who is another male and have been in a relationship for 3 month or longer
One participant must be between 17 and 29; Main partner can be any age above 17.
One participant must be HIV negative (as confirmed by rapid test)
One participant must have used at least 1 drug in the past 90 days (cocaine/crack, opiates, misuse of prescription medication, stimulants, psychedelics, ecstasy, ketamine, GHB)
One participant must have engaged in Transmission Risk Behavior (TRB) in the past 90 days
o Defined as Condom-less Anal Sex (CAS) with a casual partner and/or CAS with a non-monogamous or serodiscordant main partner
Live in the NYC or Detroit metropolitan area
Speak English
Exclusion Criteria:
· Any signs of serious mental illness or cognitive deficit
Both partners in the couple must identify as male.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| Hunter College |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34819058 | Derived | Starks TJ, D Kyre K, B Cowles C, Castiblanco J, Washington C, N Parker J, M Kahle E, Stephenson R. A full-factorial randomized controlled trial of adjunct couples HIV testing and counseling components addressing drug use and communication skills among sexual minority male couples. BMC Public Health. 2021 Nov 24;21(1):2158. doi: 10.1186/s12889-021-12208-3. |
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This study utilizes a randomized controlled trial design to evaluate the efficacy of two intervention components for couples HIV testing and counseling (CHTC): a communication skills training video and a substance use module. Participants are randomized in a full-factorial design to one of 4 conditions: CHTC as usual; CHTC + communication skills training videos; CHTC + substance use module; or CHTC plus both adjunct components.
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|
| Drug use module | Behavioral | The substance use module is administered after step 5 of CHTC and prior to the delivery of rapid HIV-test results. The couple was first asked to fill in a calendar for the past 30 days, indicating each day on which either member used drugs or consumed alcohol. Completion of the calendar is done through an ACCESS database to facilitate remote intervention delivery. After completion of the calendar, the HIV tester asked a series of debriefing questions designed to elicit the couples' perspective on their use, establish the couple's goals and limits for drug use, and make plans to achieve these goals. |
|
| 12 months |
| PrEP Uptake | self-reported receipt of a PrEP-prescription | 12 months |
| PrEP adherence | taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments | 12 months |
| New York |
| New York |
| 10018 |
| United States |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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