HIV Infections4Us Part BNCT05833074
Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
A study testing Couples HIV testing and counseling and Individual HIV testing and counseling in people with HIV Infections, run by Hunter College of City University of New York at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 65 years, men only
- Conditions the study is for
- HIV Infections
- What is being tested?
- Couples HIV testing and counseling and Individual HIV testing and counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 384 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Oct 2021to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- enrolled previously in the parent study DA050508 (NCT05000866).
- in a relationship with the same main partner with whom they completed the baseline intervention session.
- both partners in the couple must consent to continue with activities specified in this revision.
- completion of the 12-month assessment associated with participation in the parent study prior to consenting to participate in activities specified under this revision.
Who cannot join
- serious psychiatric symptoms;
- current suicidal/homicidal ideation;
- gross cognitive impairment
- a history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Hunter College
New York, New York, 10018
About this study
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.
Read the 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).
- Conditions
- HIV Infections
- Being tested
- Couples HIV testing and counseling, Individual HIV testing and counseling
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples HIV testing and counselingBehavioural
Also called CHTC
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)
Individual HIV testing and counselingBehavioural
Also called HTC
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Couples HIV testing and counseling |
| Individual HIV testing | Active comparator | Individual HIV testing and counseling. Receives: Behavioral: Individual HIV testing and counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (4)
Binge drinking
Number of days on which 5 or more drinks containing alcohol were reported on the quarterly timeline follow-back interview
Measured: 6 months
pre-exposure prophylaxis (PrEP) uptake
self-reported receipt of a PrEP-prescription
Measured: 6 months
PrEP adherence
taking 4 or more doses weekly as prescribed reported on quarterly timeline follow-back assessments
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start12 Oct 2021
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized (with equal allocation) to either couples HIV testing and counseling retesting or an individual HIV testing control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hunter College of City University of New York
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Michigan
- Responsible party
- Principal investigator, Tyrel Starks, Hunter College of City University of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833074
- Sponsor's protocol ID
- R01 DA050508-S1
- Other IDs
- R01DA050508-03S1
- Acronym
- 4Us Part B
- Status last verified
- Oct 2026
- First submitted
- 17 Apr 2023
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38349737
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Annual CHTC Retesting Among Male Couples at High Risk of HIV Infection
- ClinicalTrials.gov ID
- NCT05833074
- Acronym / sponsor ID
- 4Us Part B / R01 DA050508-S1
- Conditions
- HIV Infections
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 384 participants (estimated)
- Lead sponsor
- Hunter College of City University of New YorkUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Michigan
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized (with equal allocation) to either couples HIV testing and counseling retesting or an individual HIV testing control.
| Arm | Type | Receives |
|---|---|---|
| Couples HIV testing and counseling retesting | Experimental | Behavioral: Couples HIV testing and counselingCouples 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. |
| Individual HIV testing | Active comparator | Behavioral: Individual HIV testing and counselingIndividual HIV testing and counseling. |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- enrolled previously in the parent study DA050508 (NCT05000866).
- in a relationship with the same main partner with whom they completed the baseline intervention session.
- both partners in the couple must consent to continue with activities specified in this revision.
- completion of the 12-month assessment associated with participation in the parent study prior to consenting to participate in activities specified under this revision.
Key exclusion criteria (4 listed)
- serious psychiatric symptoms;
- current suicidal/homicidal ideation;
- gross cognitive impairment
- a history of severe physical or sexual Intimate Partner Violence (IPV) victimization in the current relationship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couples HIV testing and counselingAlso: CHTCCouples 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) | Behavioural | Couples HIV testing and counseling retesting |
| Individual HIV testing and counselingAlso: HTCIndividual 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) | Behavioural | Individual HIV testing |
Primary outcome
number of condomless anal sex acts with a casual partner in the absence of PrEP
Time frame: 6 months
Number of total anal sex acts (insertive and receptive) with casual partners reported on quarterly timeline follow-back assessments
4 secondary outcomes
Binge drinking
Time frame: 6 months
pre-exposure prophylaxis (PrEP) uptake
Time frame: 6 months
PrEP adherence
Time frame: 6 months
Drug use Frequency
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Derived from this study: PubMed 38349737Starks 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couples HIV testing and counseling and Individual HIV testing and counseling in people with HIV Infections, run by Hunter College of City University of New York at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of condomless anal sex acts with a casual partner in the absence of PrEP (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05833074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.