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Clinical trialNCT01805752CompletedInterventional

Optimizing Integrated PMTCT Services in Rural North-Central Nigeria

SponsorVanderbilt UniversityEnrollment369HIVSuspected Damage to Fetus From Viral Disease in the Mother
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Each year, an estimated 230,000 HIV-infected women in need of services for prevention of mother-to-child transmission of HIV (PMTCT) give birth in Nigeria, more than in any other nation in the world. Vanderbilt University (VU), through its affiliate, Friends in Global Health (FGH), is currently supporting HIV/AIDS services in North-Central Nigeria. These sites are predominantly rural primary health centers (PHCs) where shortages of high-cadre health care providers and insufficient laboratory capacity to perform CD4+ cell count testing have been major barriers to effective PMTCT scale-up. A systematic reassignment of patient care responsibilities coupled with the adoption of point-of-care (POC) CD4+ cell count testing will facilitate the ability of lower-cadre health providers to manage PMTCT care, including the provision and scale-up of antiretroviral treatment (ART) to pregnant women in these rural, decentralized sites. A system wherein men are facilitated to accompany their wives to ANC appointments will create an important opportunity to address entrenched gender norms. The investigators therefore propose using community and facility-based measures to encourage male partners to accompany their spouses for ANC. As influential community members, male partners can assist their spouses to utilize culturally-sensitive, sustainable and integrated PMTCT care provided by lower-cadre providers in these resource-constrained settings. The investigators propose a parallel, cluster randomized trial to evaluate the impact of a family-focused PMTCT package that includes: 1) task-shifting to lower-cadre providers at PMTCT sites; 2) POC CD4+ cell count testing; (3) integrated mother-infant care; and (4)) a prominent role for influential family members (male partners), working in close partnership with community-based health workers/volunteers. The specific aims of this study are: 1. To evaluate whether implementation of the integrated PMTCT package in primary level antenatal clinics (ANC) increases the proportion of eligible pregnant women who initiate antiretroviral medications for the purposes of PMTCT. The investigators hypothesize that the provision of the PMTCT package in intervention clinics will improve PMTCT antiretroviral uptake rates among eligible women during pregnancy from 40% to 65%. 2. To determine whether implementation of the PMTCT package improves postpartum retention of mother-infant pairs at 6 and 12 weeks. The investigators hypothesize that postpartum retention rates among mother-infant pairs attending intervention sites will be \>20% higher at 6 weeks when compared to mother-infant pairs receiving care in non-intervention sites. 3. Conduct a cost-effectiveness analysis (CEA) of the impact of this novel PMTCT intervention compared to the existing standard-of-care referral model. The investigators hypothesize that the proposed intervention will be more cost-effective than the existing model of care. In addition, two qualitative evaluations will be conducted in order to: 1. Assess client satisfaction with health services, comparing PMTCT services provided by lower level vs. higher level cadre health workers; and 2. Evaluate health care worker satisfaction with the new PMTCT service delivery model.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

12 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Niger
  • Rural Hospital

    Aguié, Agaie, Niger

Nigeria
  • Chc Agwara

    Agwara, Niger State, Nigeria

  • Rural Hospital

    Auna, Niger State, Nigeria

  • Mch Chanchaga

    Chanchaga, Niger State, Nigeria

  • Ncws Farin Doki

    Farin Doki, Niger State, Nigeria

  • Bhc Garam

    Garam, Niger State, Nigeria

  • Phc Gauraka

    Gauraka, Niger State, Nigeria

  • Bhc Ijah

    Ijah, Niger State, Nigeria

  • Bhc Izom

    Izom, Niger State, Nigeria

  • Rural Hospital

    Kaffin Koro, Niger State, Nigeria

  • Mch Paiko

    Paiko, Niger State, Nigeria

  • Bhc Wuse

    Sabon Wuse, Niger State, Nigeria

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
31 Mar 2013
Primary completion
31 Dec 2015
Completion
30 Jun 2016
Last update posted
2 Nov 2016
Registered enrollment
369
Registry id
NCT01805752

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.