Optimizing Integrated PMTCT Services in Rural North-Central Nigeria

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Vanderbilt University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Muktar Aliyu, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01805752
First received: March 4, 2013
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention
Suspected Damage to Fetus From Viral Disease in the Mother
HIV
Other: Task-shifting to lower-cadre providers at PMTCT sites
Other: POC CD4+ cell count testing
Other: integrated mother-infant care
Other: Prominent role for influential family members (male partners) in collaboration with CHWs

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Optimizing Integrated PMTCT Services in Rural North-Central Nigeria: A Cluster Randomized Trial

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • Proportion of eligible pregnant women who initiate ART for purposes of PMTCT [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    The primary outcome is the proportion of eligible women who initiate ARV medications for PMTCT. This will be determined through data in our electronic medical records system. The investigators will report the total proportion of women who initiate ARV drugs, presenting the results stratified by regimen (cART, ZDV, NVP) and type of facility. The investigators will also collect information on duration of cART.


Secondary Outcome Measures:
  • Postpartum retention of mother-infant pairs at 6 and 12 weeks post delivery [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Mother-infant pairs who have presented for their 6-week postpartum appointment will be considered active in the program (retained in care). The investigators will assess retention at both 6 week and 12-week time points in order to examine the impact of our intervention package on early (6 week) and later (12-week) postpartum retention.


Other Outcome Measures:
  • HIV-free infant survival at 6 weeks postpartum [ Time Frame: 6 weeks post delivery ] [ Designated as safety issue: No ]
    The study is not adequately powered to test this outcome.

  • Cost effectiveness analysis of impact of integrated PMTCT package [ Time Frame: 18 months ] [ Designated as safety issue: No ]

    For the CEA, the basic outcome is the cost-effectiveness ratio (CER). The CER will be computed for both intervention and the standard-of-care arms.

    The investigators will also measure the incremental cost-effectiveness ratio (ICER). A separate ICER will be calculated for the two primary study outcomes (the cost/HIV-infected women who initiated treatment for PMTCT and the cost/mother-infant pair retained in care at 6 weeks postpartum) and for the secondary outcome (cost per infant infection averted at 6 weeks of age).



Estimated Enrollment: 300
Study Start Date: March 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated family-focused PMTCT arm

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.

Other: Task-shifting to lower-cadre providers at PMTCT sites Other: POC CD4+ cell count testing Other: integrated mother-infant care Other: Prominent role for influential family members (male partners) in collaboration with CHWs
No Intervention: Standard of care
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805752

Contacts
Contact: Muktar H Aliyu, MBBS, DrPH, MPH +1-615-322-9374 muktar.aliyu@vanderbilt.edu
Contact: Awwal Gambo, BS +2348065498171 awwalgambo@gmail.com

Locations
Nigeria
CHC Agwara Not yet recruiting
Agwarra, Niger, Nigeria
Principal Investigator: Usman I Gebi, MBBS         
Rural Hospital Not yet recruiting
Auna, Niger, Nigeria
Principal Investigator: Usman I Gebi, MBBS         
MCH Chanchaga
Chanchaga, Niger, Nigeria
NCWS Farin Doki Not yet recruiting
Farin Doki, Niger, Nigeria
Principal Investigator: Usman I Gebi, MBBS         
BHC Garam Not yet recruiting
Garam, Niger, Nigeria
Principal Investigator: Usman I Gebi, MBBS         
PHC Gauraka Not yet recruiting
Gauraka, Niger, Nigeria
Principal Investigator: Usman I Gebi, MBBS         
BHC Ijah Not yet recruiting
Ijah, Niger, Nigeria
Principal Investigator: Usman I Gebi, MBBS         
BHC Izom Not yet recruiting
Izom, Niger, Nigeria
Principal Investigator: Usman I Gebi, MBBS         
Rural Hospital Not yet recruiting
Kaffin Koro, Niger, Nigeria
Principal Investigator: Usman I Gebi, MBBS         
MCH Paiko Not yet recruiting
Paiko, Niger, Nigeria
Principal Investigator: Usman I Gebi, MBBS         
BHC Wuse Not yet recruiting
Wuse, Niger, Nigeria
Principal Investigator: Usman I Gebi, MBBS         
Niger
Rural Hospital Not yet recruiting
Aguie, Agaie, Niger
Principal Investigator: Usman I Gebi, MBBS         
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Muktar H Aliyu, MBBS, DrPH, MPH Vanderbilt University
  More Information

Additional Information:
No publications provided by Vanderbilt University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Muktar Aliyu, Assistant Professor of Preventive Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01805752     History of Changes
Other Study ID Numbers: 1R01HD075075-01
Study First Received: March 4, 2013
Last Updated: March 5, 2013
Health Authority: United States: Federal Government

Keywords provided by Vanderbilt University:
Prevention of mother to child HIV transmission
HIV/AIDS

Additional relevant MeSH terms:
Virus Diseases

ClinicalTrials.gov processed this record on July 20, 2014