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Contemp Clin Trials. 2018 Aug;71:63-69. doi: 10.1016/j.cct.2018.05.020. Epub 2018 Jun 5.

Partners-based HIV treatment for seroconcordant couples attending antenatal and postnatal care in rural Mozambique: A cluster randomized trial protocol.

Author information

1
Vanderbilt University Medical Center, Vanderbilt Institute for Global Health, 2525 West End Ave, Suite 750, Nashville, TN 37203, USA; Vanderbilt University Medical Center, Department of Health Policy, 2525 West End Ave, Suite 1200, Nashville, TN 37203, USA. Electronic address: carolyn.m.audet@vanderbilt.edu.
2
Vanderbilt University Medical Center, Vanderbilt Institute for Global Health, 2525 West End Ave, Suite 750, Nashville, TN 37203, USA.
3
Friends in Global Health, Avenida Maguiguana, 32 R/C, Maputo, CP 604, Mozambique.
4
Vanderbilt University School of Medicine, Department of Biostatistics, 2525 West End Ave, Suite 11000, Nashville, TN 37203, USA.
5
Ministry of Health, Zambézia, Quelimane, Mozambique.
6
Friends in Global Health, Avenida Maguiguana, 32 R/C, Maputo, CP 604, Mozambique; Vanderbilt University Medical Center, Department of Pediatrics, 2200 Children's Way, Nashville, TN 37232, USA.
7
Vanderbilt University Medical Center, Vanderbilt Institute for Global Health, 2525 West End Ave, Suite 750, Nashville, TN 37203, USA; Vanderbilt University Medical Center, Department of Health Policy, 2525 West End Ave, Suite 1200, Nashville, TN 37203, USA.
8
Vanderbilt University Medical Center, Vanderbilt Institute for Global Health, 2525 West End Ave, Suite 750, Nashville, TN 37203, USA; Vanderbilt University Medical Center, Division of Epidemiology, Nashville, TN 37203, USA.
9
University of Michigan, Department of Health Behavior and Health Education, School of Public Health, 1415 Washington Heights, Ann Arbor, MI 48109-2029, USA.
10
University of Michigan, Combined Program in Education and Psychology & Educational Studies, School of Education, Room 4120, Ann Arbor, MI 48109, USA.
11
Division of Infectious Diseases, 100 Cambridge St, Room 1670, Massachusetts General Hospital, Boston, MA, USA; Harvard Medical School, Harvard University, 25 Shattuck St, Boston 02115, MA, USA.
12
Harvard Medical School, Harvard University, 25 Shattuck St, Boston 02115, MA, USA.
13
Yale School of Public Health, 60 College St., Suite 212, New Haven, CT, USA.

Abstract

BACKGROUND:

In resource-limited rural settings, scale-up of services to eliminate mother-to-child transmission of HIV has not been as effective as in better resourced urban settings. In sub-Saharan Africa, women often require male partner approval to access and remain engaged in HIV care. Our study will evaluate a promising male engagement intervention ("Homens para Saúde Mais" (HoPS+) [Men for Health Plus]) targeting the elimination of mother-to-child transmission in rural Mozambique.

DESIGN:

We will use a cluster randomized clinical trial design to engage 24 health facilities (12 intervention and 12 standard of care), with 45 HIV-infected seroconcordant couples per clinic. The planned intervention will engage male partners to address social-structural and cultural factors influencing eMTCT based on new couple-centered integrated HIV services.

CONCLUSIONS:

The HoPS+ study will evaluate the effectiveness of engaging male partners in antenatal care to improve outcomes among HIV-infected pregnant women, their HIV-infected male partners, and their newborn children. Our objectives are to: (1) Implement and evaluate the impact of male-engaged, couple-centered services on partners' retention in care, adherence to antiretroviral therapy, early infant diagnosis uptake, and mother-to-child transmission throughout pregnancy and breastfeeding; (2) Investigate the impact of HoPS+ intervention on hypothesized mechanisms of change; and (3) Use validated simulation models to evaluate the cost-effectiveness of the HoPS+ intervention with the use of routine clinical data from our trial. We expect the intervention to lead to strategies that can improve outcomes related to partners' retention in care, uptake of services for HIV-exposed infants, and reduced MTCT.

KEYWORDS:

Antenatal care; HIV/AIDS; Male partner engagement; Mozambique; Partners-based clinical services

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