Overview

This trial has been completed.

Conditions suspected damage to fetus from viral disease in the mother, hiv
Treatments task-shifting to lower-cadre providers at pmtct sites, poc cd4+ cell count testing, integrated mother-infant care, prominent role for influential family members (male partners) in collaboration with chws
Sponsor Vanderbilt University
Collaborator National Institutes of Health (NIH)
Start date March 2013
End date December 2015
Trial size 369 participants
Trial identifier NCT01805752, 1R01HD075075-01

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Intervention package 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. Patients attending sites randomized to this arm will also receive group health education; opt-out HIV testing, same-day HIV test results; infant feeding counseling; HBC services; infant prophylaxis, early infant diagnosis, and linkage to family spacing services, if desired.
task-shifting to lower-cadre providers at pmtct sites
poc cd4+ cell count testing
integrated mother-infant care
prominent role for influential family members (male partners) in collaboration with chws
(No Intervention)
Arm will receive standard of care activities, namely: group health education; opt-out HIV testing, same-day HIV test results; infant feeding counseling; HBC services; infant prophylaxis, early infant diagnosis, linkage to family spacing services, if desired.

Primary Outcomes

Measure
Proportion of eligible pregnant women who initiate ART for purposes of PMTCT
time frame: 18 months

Secondary Outcomes

Measure
Postpartum retention of mother-infant pairs at 6 and 12 weeks post delivery
time frame: 12 weeks

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. HIV-infected women (and their infants) who present to ANC or delivery with unknown HIV status; 2. HIV-infected women (and their infants) with previous history of ARV prophylaxis or treatment, but who are not on prophylaxis or treatment at the time of presentation for antenatal care or delivery. Exclusion Criteria: HIV-infected women with known status who are on ARV prophylaxis or treatment at the time of presentation to ANC.

Additional Information

Official title Optimizing Integrated PMTCT Services in Rural North-Central Nigeria: A Cluster Randomized Trial
Principal investigator Muktar H Aliyu, MBBS, DrPH
Description The investigators propose a parallel cluster randomized trial to evaluate the effects of the intervention. Twelve primary and secondary level health care facilities in Niger State will be randomized to the control (standard-of-care) or intervention arms. The investigators will match clinics on patient volume and level of facility and randomize to intervention and standard-of-care/control arms - 6 clinics per arm. The investigators will make the proposed intervention available to all eligible women attending clinics that are randomized to the intervention arm. The drug regimens and general HIV care services provided as part of the package are standard of care, based on Nigerian national guidelines. Inclusion Criteria: (1) HIV-infected women (and their infants) who present to ANC or delivery with unknown HIV status; (2) HIV-infected women (and their infants) with previous history of ARV prophylaxis or treatment, but who are not on prophylaxis or treatment at the time of presentation for antenatal care or delivery. Exclusion Criteria: HIV-infected women with known status who are on ARV prophylaxis or treatment at the time of presentation to ANC. Home-based care (HBC) workers will track clients who miss appointments at control and intervention sites. The HBC workers will document clients as terminated care if they: (1) discontinued services due to death or personal decision; (2) transferred their care to another clinic; or (3) are lost to follow-up (defined as being 90 days late for a clinic appointment plus 5 failed attempts at tracking the client). Clients will not receive any remuneration for participating in the study. Clients will be allowed to discontinue participation and decide that their medical data cannot be used in the analysis.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Vanderbilt University.