Partners-based HIV Treatment for Couples Attending Antenatal Care
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ClinicalTrials.gov Identifier: NCT03149237 |
Recruitment Status :
Recruiting
First Posted : May 11, 2017
Last Update Posted : March 5, 2020
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Condition or disease | Intervention/treatment | Phase |
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Human Immunodeficiency Virus | Behavioral: Couples-based services | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 3240 participants |
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 |
Official Title: | Partners-based HIV Treatment for Sero-concordant Couples Attending Antenatal Care |
Actual Study Start Date : | November 20, 2017 |
Estimated Primary Completion Date : | April 2022 |
Estimated Study Completion Date : | April 2022 |
Arm | Intervention/treatment |
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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.
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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.
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Behavioral: Couples-based services
Couples-based services, including treatment, counseling and peer mentoring in the community. |
- 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).
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03149237
Contact: Sara Von Rompaey, MD | 258823105272 | sara.vonrompaey@fgh.org.mz | |
Contact: Lazaro Calvo, PhD | 258826430149 | lazaro.calvo@fgh.org.mz |
Mozambique | |
Minisitry of Health Health Facility | Recruiting |
Pebane, Zambezia, Mozambique | |
Contact: Sara van Rompaey, MD 258847266921 sara.vanrompaey@fgh.org.mz | |
Contact: Caroline DeSchacht, MD 258823393460 caroline.deschacht@fgh.org.mz |
Study Director: | Erin Graves, MPH, BSN | Vanderilt University |
Responsible Party: | Carolyn Audet, Assistant Professor of Health Policy, Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT03149237 |
Other Study ID Numbers: |
170365 R01MH113478-01 ( U.S. NIH Grant/Contract ) |
First Posted: | May 11, 2017 Key Record Dates |
Last Update Posted: | March 5, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Mozambique Couples-based services HIV/AIDS Ante-natal Care |
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Immune System Diseases Lentivirus Infections Retroviridae Infections |
RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases |