Couples HIV Testing and Counseling for HIV Retesting

(4Us Part B Trial)

Recruiting 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

384 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Couples HIV testing and counseling?

Research shows that Couples HIV Testing and Counseling (CHTC) is effective in helping couples share their HIV status with each other and connect to HIV care. It is also found to be safe and acceptable for male couples, with similar satisfaction levels compared to individual testing. ^{1 2 3 4 5}

Is Couples HIV Testing and Counseling safe for participants?

Research shows that Couples HIV Testing and Counseling is generally safe for participants. A study with male couples in Atlanta found no significant difference in intimate partner violence or relationship breakups compared to individual testing, indicating it is as safe as individual counseling. ^{3 4 6 7 8}

How is Couples HIV Testing and Counseling different from other HIV treatments?

Couples HIV Testing and Counseling is unique because it involves both partners getting tested and receiving counseling together, which can improve communication and relationship dynamics, unlike individual testing where partners are tested separately. ^{3 4 9 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

Enrolled previously in the parent study DA050508 (NCT05000866)

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

My partner and I agree to follow the study's required activities.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Results of a Couples-Based Randomized Controlled Trial Aimed to Increase Testing for HIV. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Reducing sexual risk behavior among steady heterosexual serodiscordant couples in a testing and counseling program. [2009]

3. France pubmed.ncbi.nlm.nih.gov

[Enhanced prenatal HIV couple oriented counselling session and couple communication about HIV (ANRS 12127 Prenahtest Trial)]. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

Safety and acceptability of couples HIV testing and counseling for US men who have sex with men: a randomized prevention study. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of a demand-creation intervention for couples' HIV testing services among married or cohabiting individuals in Rakai, Uganda: a cluster-randomized intervention trial. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

HIV-negative partnered men's attitudes toward using an in-home rapid HIV test and associated factors among a sample of US HIV-Negative and HIV-discordant male couples. [2018]

7. Ireland pubmed.ncbi.nlm.nih.gov

Perceptions of couple HIV counseling and testing in Botswana: a stakeholder analysis. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The impact of HIV couple testing and counseling on social support among pregnant women and their partners in Lilongwe, Malawi: an observational study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Gay male couples' attitudes toward using couples-based voluntary HIV counseling and testing. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

'Testing Together Challenges the Relationship': Consequences of HIV Testing as a Couple in a High HIV Prevalence Setting in Rural South Africa. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Sexual behavior of HIV discordant couples after HIV counseling and testing. [2022]