Clinical trial NCT01805752: Optimizing Integrated PMTCT Services in Rural North-Central Nigeria
Official title: Optimizing Integrated PMTCT Services in Rural North-Central Nigeria: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suspected Damage to Fetus From Viral Disease in the Mother
HIV
Keywords: Prevention of mother to child HIV transmission
HIV/AIDS
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2013-03-06
Enrollment: 369
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of eligible pregnant women who initiate ART for purposes of PMTCT
timeFrame: 18 months
Secondary outcomes:
measure: Postpartum retention of mother-infant pairs at 6 and 12 weeks post delivery
timeFrame: 12 weeks
Other outcomes:
measure: HIV-free infant survival at 6 weeks postpartum
timeFrame: 6 weeks post delivery
measure: Cost effectiveness analysis of impact of integrated PMTCT package
timeFrame: 18 months
Locations:
city: Agwarra
country: Nigeria
facility: CHC Agwara
state: Niger
city: Auna
country: Nigeria
facility: Rural Hospital
state: Niger
city: Chanchaga
country: Nigeria
facility: MCH Chanchaga
state: Niger
city: Farin Doki
country: Nigeria
facility: NCWS Farin Doki
state: Niger
city: Garam
country: Nigeria
facility: BHC Garam
state: Niger
city: Gauraka
country: Nigeria
facility: PHC Gauraka
state: Niger
city: Ijah
country: Nigeria
facility: BHC Ijah
state: Niger
city: Izom
country: Nigeria
facility: BHC Izom
state: Niger
city: Kaffin Koro
country: Nigeria
facility: Rural Hospital
state: Niger
city: Paiko
country: Nigeria
facility: MCH Paiko
state: Niger
city: Wuse
country: Nigeria
facility: BHC Wuse
state: Niger
city: Aguie
country: Niger
facility: Rural Hospital
state: Agaie
Study officials:
affiliation: Vanderbilt University
name: Muktar H Aliyu, MBBS, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Aliyu MH, Blevins M, Audet C, Shepherd BE, Hassan A, Onwujekwe O, Gebi UI, Kalish M, Lindegren ML, Vermund SH, Wester CW. Optimizing PMTCT service delivery in rural North-Central Nigeria: protocol and design for a cluster randomized study. Contemp Clin Trials. 2013 Sep;36(1):187-97. doi: 10.1016/j.cct.2013.06.013. Epub 2013 Jun 29.
citation: Aliyu MH, Blevins M, Audet CM, Kalish M, Gebi UI, Onwujekwe O, Lindegren ML, Shepherd BE, Wester CW, Vermund SH. Integrated prevention of mother-to-child HIV transmission services, antiretroviral therapy initiation, and maternal and infant retention in care in rural north-central Nigeria: a cluster-randomised controlled trial. Lancet HIV. 2016 May;3(5):e202-11. doi: 10.1016/S2352-3018(16)00018-7. Epub 2016 Feb 24.