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NCT03149237

Partners-based HIV Treatment for Couples Attending Antenatal Care

Completed NA Results posted Last updated 21 August 2023
What this trial tests

NA trial testing Couples-based services in Human Immunodeficiency Virus in 2,160 participants. Completed in 23 July 2023.

Timeline
16 November 2017
Primary endpoint
1 March 2023
23 July 2023

Quick facts

Lead sponsorVanderbilt University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment2,160
Start date16 November 2017
Primary completion1 March 2023
Estimated completion23 July 2023
Sites1 location across Mozambique

Drugs / interventions tested

Conditions studied

Sponsor

Vanderbilt University Medical Center

Who can join

18 and older, any sex, with Human Immunodeficiency Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Proportion of Time on Medication Among Pregnant Women Primary · 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.

GroupValue95% CI
Standard of Care0.67± 0.26
Couples-based Services0.66± 0.27
Proportion of Days With Medication Among Male Partner Primary · 12 months

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

GroupValue95% CI
Standard of Care0.47± 0.31
Couples-based Services0.55± 0.29

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Partners-based HIV treatment for seroconcordant couples attending antenatal and postnatal care in rural Mozambique: A cluster randomized trial protocol.
    Audet CM, Graves E, Barreto E, De Schacht C, et al · · 2018 · cited 16× · PMID 29879469 · DOI 10.1016/j.cct.2018.05.020
  2. Feasibility and Acceptability Pilot Test of Connecting Latinos en Parejas: A Couples-Based HIV Prevention Intervention for Latino Male Couples.
    Martinez O, Fernandez MI, Yang C, Wu E, et al · · 2023 · cited 6× · PMID 37096329 · DOI 10.1177/15579883231167106
  3. Partner-Based HIV Treatment for Seroconcordant Couples Attending Antenatal and Postnatal Care in Rural Mozambique: A Cluster Randomized Controlled Trial.
    Audet CM, Graves E, Shepherd BE, Prigmore HL, et al · · 2024 · cited 3× · PMID 38905476 · DOI 10.1097/qai.0000000000003440
  4. Effect of a storytelling intervention on the retention of serodiscordant couples in ART/PrEP services at antenatal clinic in Namacurra province in Zambézia, Mozambique.
    Audet CM, Graves E, Emílio AM, Matino A, et al · · 2021 · cited 3× · PMID 34095604 · DOI 10.1016/j.conctc.2021.100782
  5. Interpersonal reactivity index adaptation among expectant seroconcordant couples with HIV in Zambézia Province, Mozambique.
    Sack DE, Frisby MB, Diemer MA, De Schacht C, et al · · 2020 · cited 3× · PMID 32859272 · DOI 10.1186/s40359-020-00442-0
  6. Healthcare Providers' Perspectives on a Novel Couple-Based HIV Treatment Intervention: A Qualitative Assessment of the Facilitators, Barriers, and Proposed Improvements to Implementation in Zambézia Province, Mozambique.
    Graves E, Brooks HL, De Schacht C, Emílio A, et al · · 2024 · cited 1× · PMID 38151664 · DOI 10.1007/s10461-023-04224-8
  7. "If It Weren't for This, We'd Be Sick"-Perspectives From Participants of a Couple-Based HIV Treatment and Support Program During Prenatal and Postpartum Periods in Zambézia Province, Mozambique.
    Brooks HL, Graves E, De Schacht C, Emílio A, et al · · 2024 · cited 1× · PMID 38032747 · DOI 10.1097/qai.0000000000003351
  8. Healthcare resource use among participants in a randomized trial of partner-based HIV treatment for seroconcordant couples in antenatal and postnatal care in rural Mozambique.
    Coskun E, Graves E, De Schacht C, Audet CM, et al · · 2026 · PMID 41877279 · DOI 10.1186/s13104-026-07782-x

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03149237.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing