Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Optimizing Integrated PMTCT Services in Rural North-Central Nigeria: A Cluster Randomized Trial
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.


Options:
A: Arm Label: Enhanced usual care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: ED-only; Type: EXPERIMENTAL; Interventions: Behavioral: CAPE | Arm Label: ED-plus-home; Type: EXPERIMENTAL; Interventions: Behavioral: CAPE, Behavioral: CHW home visits | Intervention Type: BEHAVIORAL; Name: CAPE; Assigned to Arm(s): ED-only, ED-plus-home | Intervention Type: BEHAVIORAL; Name: CHW home visits; Assigned to Arm(s): ED-plus-home
B: Arm Label: Direct & Digital; Type: OTHER; Interventions: Other: Digital Engagement, Other: Direct Engagement | Arm Label: Direct & Registry; Type: OTHER; Interventions: Other: Direct Engagement | Arm Label: Digital & Registry; Type: OTHER; Interventions: Other: Digital Engagement | Arm Label: Registry; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Digital Engagement; Assigned to Arm(s): Digital & Registry, Direct & Digital | Intervention Type: OTHER; Name: Direct Engagement; Assigned to Arm(s): Direct & Digital, Direct & Registry
C: Arm Label: Integrated family-focused PMTCT arm; Type: EXPERIMENTAL; Interventions: 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 | Arm Label: Standard of care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Task-shifting to lower-cadre providers at PMTCT sites; Assigned to Arm(s): Integrated family-focused PMTCT arm | Intervention Type: OTHER; Name: POC CD4+ cell count testing; Assigned to Arm(s): Integrated family-focused PMTCT arm | Intervention Type: OTHER; Name: integrated mother-infant care; Assigned to Arm(s): Integrated family-focused PMTCT arm | Intervention Type: OTHER; Name: Prominent role for influential family members (male partners) in collaboration with CHWs; Assigned to Arm(s): Integrated family-focused PMTCT arm
D: Arm Label: Multifaceted Strategy; Type: EXPERIMENTAL; Interventions: Behavioral: Multifaceted Strategy | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Multifaceted Strategy; Assigned to Arm(s): Multifaceted Strategy

Answer: C