Partners-based HIV Treatment for Couples Attending Antenatal Care

• ClinicalTrials.gov Identifier: NCT03149237
• Recruitment Status: Recruiting
• First Posted: May 11, 2017
• Last Update Posted: March 12, 2021
• Sponsor: Vanderbilt University Medical Center
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Carolyn Audet, Vanderbilt University Medical Center

Tracking Information

• First Submitted Date: May 3, 2017
• First Posted Date: May 11, 2017
• Last Update Posted Date: March 12, 2021
• Actual Study Start Date: November 16, 2017
• Estimated Primary Completion Date: March 1, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 2, 2020)

HIV care and treatment retention [ Time Frame: 12 months ]

Our primary outcome is patient retention, defined as monthly medication pick-up. Specifically, any ART medication pick-up between days 16 and 45 will count as medication pick-up during month 1, any medication pick-up between days 46 and 75 will count as medication pick-up during month 2, and so forth, up until 12 months (i.e., medication pick-up between day 346 and 375).

Original Primary Outcome Measures (submitted: May 9, 2017)

Retention [ Time Frame: 12 months ]

Maternal retention in HIV care and treatment (defined as not being more than 59 days late for a scheduled clinical visit)

Current Secondary Outcome Measures (submitted: March 2, 2020)

Proportion of time on medication [ Time Frame: 12 months ]

Specifically, every patient is given 30 days to pick up their medication, with a grace period of 5 days. If a patient picks up medication more than 35 days from their last pick-up, then they will be considered not on their medication from day 30 until the day of their next pick-up, at which time they will be assumed to be on medication again; this will be calculated over the course of the one-year follow-up.

Original Secondary Outcome Measures (submitted: May 9, 2017)

HIV Viral Load [ Time Frame: 12 months ]

Maternal HIV RNA (Viral Load) per a milliliter of blood

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Partners-based HIV Treatment for Couples Attending Antenatal Care
• Official Title: Partners-based HIV Treatment for Sero-concordant Couples Attending Antenatal Care
• Brief Summary: The purpose of this R01 proposal is to evaluate the clinical impact, hypothesized mechanisms of behavior change, and cost-effectiveness of a partners-focused integrated elimination of mother-to-child transmission of HIV (EMTCT) package comprised of: 1) antenatal care-based couples HIV testing, ART enrollment, and care for sero-concordant HIV+ expectant couples; (2) Couples-based treatment in the post-partum period; (3) Couple-based education and skills building; and (4) Treatment continuity with the support of expert-patient (peer) supporters from couples who have successfully navigated EMTCT. This innovative approach to scaling up EMTCT services, if proven feasible and effective, will be adopted in President's Emergency Plan for AIDS Relief (PEPFAR) programs to accelerate progress toward EMTCT and helping families with HIV infection live long, healthy lives.
• Detailed Description: In severely resource-limited rural settings, scale-up of services to eliminate mother-to-child transmission of HIV (EMTCT) has failed to provide effective HIV testing and antiretroviral therapy (ART) coverage for women in highest prevalence southern African regions. All HIV-infected pregnant women are now eligible for life-long antiretroviral therapy (ART) (Option B+), but retention among women enrolled through Option B+ programs remains sub-optimal. In sub-Saharan Africa (SSA) it is common for women to require male partner approval to access and remain engaged in HIV-related health services. Despite the likelihood that male involvement would improve program coverage and adherence, the evidence base for effective interventions to involve male partners in HIV testing and treatment through antenatal care (ANC) point of care is very limited. Furthermore, whether such strategies are indeed cost-effective for improving outcomes of HIV-diagnosis and treatment in pregnancy is unknown. This proposal seeks to address these key gaps in the evidence base and guide scale-up by evaluating a promising male engagement intervention ("Homens para Saúde" (HoPS)+ [Men for Health]) targeting EMTCT in Mozambique through a clinic-randomized trial. This study will engage 24 ANC clinics; 12 intervention and 12 standard of care, with 45 HIV-infected couples per clinic where currently >60% of couples attend their first ANC visit together. The planned intervention addresses social-structural and cultural factors influencing EMTCT through the creation of couples-centered integrated HIV services, including: (1) ANC-based couples HIV testing, ART enrollment, and care for sero-concordant HIV+ expectant couples; (2) Couple-based treatment in the post-partum period; (3) Couple-based education and skills building; and (4) Treatment continuity with the support of expert-patient (peer) supporters from couples who have successfully navigated EMTCT. Given that 8.0% of all pregnant women and 7.2% of their partners tested HIV-positive during ANC visits in 2015 (FGH monitoring and evaluation [M&E] data), the investigators pioneering work in Mozambique's rural Zambézia province suggests that innovative strategies are essential to engaging HIV-infected male partners in antenatal care (ANC) in order to achieve EMTCT and to improve substantially the health of the mothers. This team of Mozambican and U.S. investigators has a proven record of international HIV research success and they have specific recent experience with EMTCT cluster randomized trials, male-engagement in ANC services, and cost-effectiveness analysis of HIV programs. The specific aims of this study are: (1) To implement and evaluate the impact of male-engaged, couples-centered services on retention in care, adherence to ART, and early infant diagnosis among HIV+ pregnant women and their HIV+ male partners through a cluster-randomized control trial (RCT); (2) To investigate the impact of HoPS+ on hypothesized mechanisms of change; and (3) To use validated simulation models to evaluate cost-effectiveness of the HoPS+ intervention with the use of programmatic provincial monitoring and evaluation data and data from the trial results.
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The 12 clinics randomly assigned to the intervention arm will receive a combination of community and clinical services, including: (1) ANC-based couples HIV testing, couples-based treatment enrollment, and clinical care for sero-concordant HIV+ expectant couples; (2) couple-centered treatment in the post-partum period; (3) couples-based education and skills building during the ANC and post-partum period; and (4) treatment continuity support by expert-patient (peer) navigators selected among couples who have successfully navigated EMTCT. The 12 clinics randomized to the control arm will continue to provide standard of care EMTCT services that include: standard HoPS male engagement (male invitation to ANC services and couples HIV testing), opt-out rapid HIV testing of all pregnant women attending ANC, HIV-specific counseling and support for all women who test positive, provision of cotrimoxazole prophylaxis, and universal ART, as per option B+ guidelines.

Masking: None (Open Label)
Primary Purpose: Supportive Care

• Condition: Human Immunodeficiency Virus

Intervention

Behavioral: Couples-based services

Couples-based services, including treatment, counseling and peer mentoring in the community.

Study Arms

• No Intervention: Standard of Care
  The 12 clinics randomized to the control arm will continue to provide standard of care (SOC) EMTCT services that include: standard HoPS male engagement (male invitation to ANC services and couples HIV testing), opt-out rapid HIV testing of all pregnant women attending ANC, HIV-specific counseling and support for all women who test positive, provision of cotrimoxazole prophylaxis, and universal ART, as per option B+ guidelines.
• Experimental: Couples-based Services
  The 12 clinics randomly assigned to the intervention arm will receive a combination of community and clinical EMTCT services, including: (1) ANC-based couples HIV testing, couples-based treatment enrollment, and clinical care for sero-concordant HIV+ expectant couples; (2) couple-centered treatment in the post-partum period at the EID clinic; (3) couples-based education and skills building during the ANC and post-partum period; and (4) treatment continuity support by expert-patient (peer) navigators selected among couples who have successfully navigated EMTCT.
  Intervention: Behavioral: Couples-based services

• Publications *: Sack DE, Frisby MB, Diemer MA, De Schacht C, Graves E, Kipp AM, Emílio A, Matino A, Barreto E, Van Rompaey S, Wallston KA, Audet CM. Interpersonal reactivity index adaptation among expectant seroconcordant couples with HIV in Zambézia Province, Mozambique. BMC Psychol. 2020 Aug 28;8(1):90. doi: 10.1186/s40359-020-00442-0.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 9, 2017): 3240
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2022
• Estimated Primary Completion Date: March 1, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Couples, one HIV+ pregnant woman and her infected male partner, will be eligible to participate if the woman's due date is >2 weeks from enrollment. Both persons must also be 18 years or older, able to give consent, willing to consent to an infant record search, and must agree to enroll in ART together.

Exclusion Criteria:

• Couples will not be eligible to participate in the study if the woman is not pregnant, if both persons are not HIV+, if either person is younger than 18 years, if one member of the couple is unwilling to enroll in ART or consent to the infant record search, or if one member of the couple is unable to give consent due to mental limitations.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sara Von Rompaey, MD; 258823105272; sara.vonrompaey@fgh.org.mz

Contact: Lazaro Calvo, PhD; 258826430149; lazaro.calvo@fgh.org.mz

• Listed Location Countries: Mozambique

Administrative Information

• NCT Number: NCT03149237
• Other Study ID Numbers: 170365; R01MH113478-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: After the study is completed and the results published, the investigators will upload de-identified data to ICPSR.

• Responsible Party: Carolyn Audet, Vanderbilt University Medical Center
• Study Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute of Mental Health (NIMH)

Investigators

• Study Director: Erin Graves, MPH, BSN; Vanderilt University

• PRS Account: Vanderbilt University Medical Center
• Verification Date: March 2021