Couples HIV Testing and Counseling for HIV Retesting

(4Us Part B Trial)

Enrolling by invitation at 1 trial location

Age: Any Age

Sex: Male

Trial Phase: Academic

Sponsor: Hunter College of City University of New York

Disqualifiers: Psychiatric symptoms, Suicidal ideation, Cognitive impairment, IPV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of HIV testing and counseling for couples. The goal is to determine if couples retesting together proves more effective than individual testing. Follow-up sessions will assess results and behaviors after 3 and 6 months. Couples who participated in a related study and remain in the same relationship may be eligible. As an unphased trial, this study offers couples the chance to contribute to important research that could enhance HIV testing strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that couples HIV testing and counseling is safe?

Research shows that couples HIV testing and counseling (CHTC) is safe for male couples. Studies indicate that CHTC is as acceptable as individual testing and counseling for men with their main partners, meaning people generally handle the process well. No reports of serious negative effects have emerged from this approach in the studies available, suggesting that CHTC is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how couples HIV testing and counseling might improve retesting rates compared to individual testing. Unlike standard individual HIV testing, this approach involves both partners, which can encourage open communication and mutual support, potentially leading to better adherence to retesting schedules. This method could also strengthen relationships and reduce the stigma associated with HIV testing, making it a promising strategy for more effective HIV prevention and management.

What evidence suggests that couples HIV testing and counseling retesting is effective for HIV prevention?

Research has shown that when couples get tested and receive counseling for HIV together, it can greatly reduce the chance of spreading the virus. In this trial, one group will receive Couples HIV testing and counseling, which studies have found can lower the risk of HIV transmission by 47–79%, preventing many infections. Testing both partners simultaneously allows them to learn about their HIV status and encourages safer behaviors. One study found that this method significantly reduced the risk of HIV for women compared to when they are tested alone. Overall, couples testing helps partners support each other and make healthier choices. Meanwhile, another group in this trial will receive Individual HIV testing and counseling, serving as an active comparator. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for male couples at high risk of HIV who completed a previous study (NCT05000866) and its 12-month assessment. Both partners must consent to participate, be in the same relationship as before, and not have serious psychiatric symptoms, suicidal/homicidal thoughts, cognitive impairments or severe IPV history.

Inclusion Criteria

Completion of the 12-month assessment associated with participation in the parent study prior to consenting to participate in activities specified under this revision

Enrolled previously in the parent study DA050508 (NCT05000866)

In a relationship with the same main partner with whom they completed the baseline intervention session

Exclusion Criteria

Presence of serious psychiatric symptoms at the 12-month follow-up

Current suicidal/homicidal ideation at the 12-month follow-up

Gross cognitive impairment at the 12-month follow-up

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Intervention

Participants are randomized to either couples HIV testing and counseling (CHTC) retesting or individual HIV testing control

12 months

1 visit (in-person)

Follow-up

Follow-up assessments conducted 3 and 6 months after retesting to monitor outcomes such as PrEP uptake and adherence, binge drinking, and drug use frequency

6 months

2 visits (in-person)

Open-label extension (optional)

Participants who remain in the same relationship after 12-month follow-up may opt to continue in the study

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Couples HIV testing and counseling
• Individual HIV testing and counseling

Trial Overview The study compares annual Couples HIV Testing and Counseling (CHTC) retesting with individual testing among high-risk male couples. Participants are randomly assigned to one of these two groups and followed up after 3 and 6 months to evaluate efficacy.

How Is the Trial Designed?

Group I: Couples HIV testing and counseling retesting Experimental Treatment 1 Intervention

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.

Group II: Individual HIV testing Active Control 1 Intervention

Individual HIV testing and counseling.

Who Is Running the Clinical Trial?

Hunter College of City University of New York

Lead Sponsor

Trials

43

Recruited

10,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Published Research Related to This Trial

A couples-based intervention significantly increased the uptake of couples HIV testing and counseling (CHTC) from 12% in the control group to 42% in the intervention group, demonstrating its efficacy in promoting mutual disclosure and linkage to care.

The intervention also reduced the time it took for couples to participate in CHTC, highlighting its potential to enhance public health efforts in communities heavily affected by HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV. Darbes, LA., McGrath, NM., Hosegood, V., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4310810/

Couple-based HIV counseling and testing: a risk reduction ... The couple-based HIV testing and counseling intervention significantly reduced women's overall HIV risk compared to a standard-of-care individual HIV testing ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3608180/

Effectiveness of Couple-Based HIV Counseling and Testing ... A randomized trial was conducted to test the effectiveness of couple-based HIV counseling and testing (CB-HIV-CT) and women-only relationship-focused HIV ...

3. researchprotocols.org researchprotocols.org/2024/1/e53023/

Comparing Repeated (Annual) Couples HIV Testing and ... The purpose of this study is to evaluate the efficacy of annual CHTC retesting to reduce indicators of sexual risk relative to routine ...

4. academic.oup.com academic.oup.com/ije/article/48/1/217/5144579

HIV testing and counselling couples together for affordable ... This couple-centred approach reduced HIV transmission by 47–79% and prevented an estimated 58% of infections at US $659 per infection averted.

5. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(22)00342-X/fulltext

HIV Voluntary Counseling and Testing (VCT ... Our meta-analysis identified VCT-HIV as protective for sexual risk behaviors for among KP, the results are limited to MSM and PWID.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3954957/

Safety and Acceptability of Couples HIV Testing ... Based on the preliminary data, CHTC is safe for male couples, and it is equally acceptable to iVCT for men who have main partners.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23995295/

Safety and acceptability of couples HIV testing ... Based on the preliminary data, CHTC is safe for male couples, and it is equally acceptable to iVCT for men who have main partners. Keywords: HIV; male ...

8. stacks.cdc.gov stacks.cdc.gov/view/cdc/46850

Couples HIV testing and counseling (CHTC) in health care ... Importance of Data Collection, Reporting, and Data Use (5 minutes). Key Points Regarding CHTC Data Collection (10 minutes). Examples of Data Collection Tools ...