Partners-based HIV Treatment for Couples Attending Antenatal Care

NCT03149237 | Completed Results DMC

• 2 other identifiers: 170365R01MH113478-01
• Study Type: interventional
• Target: 2,160
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Immunodeficiency Virus

Keywords

Mozambique; Couples-based services; HIV/AIDS; Ante-natal Care

Outcome Measures

Primary Outcomes (2)

• Proportion of Time on Medication Among Pregnant Women

  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.

  12 months

• Proportion of Days With Medication Among Male Partner

  Proportion of days with medication (based on date of pick up and the number of pills provided by the pharmacy) among male partners

  12 months

Study Arms (2)

Standard of Care

NO INTERVENTION

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.

Couples-based Services

EXPERIMENTAL

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.

Behavioral: Couples-based services

Interventions

Couples-based services BEHAVIORAL

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

Couples-based Services

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Minisitry of Health Health Facility

Pebane, Zambezia Province, Mozambique

Location

Related Publications (2)

• Audet CM, Graves E, Shepherd BE, Prigmore HL, Brooks HL, Emilio A, Matino A, Paulo P, Diemer MA, Frisby M, Sack DE, Aboobacar A, Barreto E, Van Rompaey S, De Schacht C. Partner-Based HIV Treatment for Seroconcordant Couples Attending Antenatal and Postnatal Care in Rural Mozambique: A Cluster Randomized Controlled Trial. J Acquir Immune Defic Syndr. 2024 Jul 1;96(3):259-269. doi: 10.1097/QAI.0000000000003440.

  PMID: 38905476 DERIVED

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

  PMID: 32859272 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Dr. Carolyn Audet
• Organization: Vanderbilt University Medical Center

carolyn.m.audet@vumc.org

615-343-2418

Study Officials

• Erin Graves, MPH, BSN

  Vanderilt University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Health Policy

Model Details: 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.

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 11, 2017
• Study Start: November 16, 2017
• Primary Completion: March 1, 2023
• Study Completion: July 23, 2023
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)