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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA050508-03S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| University of Michigan | OTHER |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Couples HIV testing and counseling retesting | Experimental | Couples HIV testing and counseling is completed following Centers for Disease Control and Prevention (CDC) standard protocol. Participants also complete any adjunct CHTC components associated with their originally assigned condition in NCT05000866. |
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| Individual HIV testing | Active Comparator | Individual HIV testing and counseling. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Couples HIV testing and counseling | Behavioral | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| number of condomless anal sex acts with a casual partner in the absence of PrEP | Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments | 6 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 | 6 months |
| pre-exposure prophylaxis (PrEP) uptake | self-reported receipt of a PrEP-prescription |
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Inclusion:
Exclusion: any of the following at the 12-month follow-up:
cismale
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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 |
|---|---|---|---|
| 38349737 | Derived | Starks TJ, Kyre K, Castiblanco J, Parker JN, Kahle E, Stephenson R, Cain D. Comparing Repeated (Annual) Couples HIV Testing and Counseling to Individual HIV Testing and Counseling Among Male Couples at High Risk of HIV Infection: Protocol for a Randomized Control Trial. JMIR Res Protoc. 2024 Feb 13;13:e53023. doi: 10.2196/53023. |
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Participant-level data will be shared upon request and at the discretion of the study PI under the terms of a memorandum of understanding signed by officials at the transmitting and receiving institutions.
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Participants are randomized (with equal allocation) to either couples HIV testing and counseling retesting or an individual HIV testing control.
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Research assistants are not given access to information about study condition.
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| Individual HIV testing and counseling | Behavioral | 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) |
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| 6 months |
| PrEP adherence | taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments | 6 months |
| Drug use Frequency | 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 | 6 months |
| New York |
| New York |
| 10018 |
| United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| 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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| ID | Term |
|---|---|
| D003376 | Counseling |
| C119825 | chitinase C |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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