Early ART Initiation Among HIV-positive Pregnant Women in Central Mozambique

NCT02371265 | Completed

• 2 other identifiers: 427731R01HD074557-01
• Study Type: interventional
• Target: 761
• Locations: 1 country
• Sites: 1

Brief Summary

The overall objective of the study is to develop and test a pilot intervention in central Mozambique to implement the new WHO "Option B+" guidelines that seek to increase the proportion of HIV-positive pregnant women in six antenatal care clinics who start antiretroviral therapy (ART) prior to delivery, and are retained in care after 90- days.

Conditions

HIV

Keywords

HIV; Mozambique; antenatal care; adherence; retention; pregnancy; HIV-positive mothers retained in ART after 90 days

Outcome Measures

Primary Outcomes (2)

• Retention at 30 days

  The primary outcome measure for Aim 3 is the proportion of HIV-positive pregnant women tested at the participating ANC sites that successfully initiates appropriate ART and returns for their scheduled 30-day visit for pharmacy refill and evaluation within 45 days.

  45 days

• Adherence at 90 days

  The primary outcome measure for Aim 4 is the ART adherence rate through 90 days after ART initiation.

  90 days

Study Arms (2)

Adherence and retention intervention

EXPERIMENTAL

Implementation of adherence and retention package

Other: Adherence and retention package

Control

NO INTERVENTION

Clusters continue without intervention package

Interventions

Adherence and retention package OTHER

Based on formative research findings, the following core components of the B+ study intervention have been designed and will be stepped in at the study sites to improve early retention in care and adherence: * Workflow modification: 1) Redefinition of key roles of MCH nurses and task shifting to community health workers (CHW's), and 2) enhanced patient tracking via improved management of registries/charts; * Adherence and retention package: 1) Creation of "Adherence Committees" at each site to coordinate and systematize patient follow-up, 2) active patient follow-up and home visits by community health workers (CHWs or activistas), 3) use of text messaging to patients by MCH nurses, 4) improved and intensified counseling coordinated with active CHW and text follow-up, and 5) intensified and improved Option B+ training and supportive supervision.

Adherence and retention intervention

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women who test HIV-positive in antenatal care services at target health facilities

You may not qualify if:

• Pregnant women who arrived at health facilities who already have tested positive
• HIV-positive pregnant women who cannot start ART

Sponsors & Collaborators

• University of Washington: lead
• Health Alliance International: collaborator
• Beira Operations Research Center, Mozambique Ministry of Health: collaborator

Study Sites (1)

Beira Operations Research Center

Beira, Sofala, Mozambique

Location

Related Publications (1)

• Cowan JF, Micek M, Cowan JF, Napua M, Hoek R, Gimbel S, Gloyd S, Sherr K, Pfeiffer JT, Chapman RR. Early ART initiation among HIV-positive pregnant women in central Mozambique: a stepped wedge randomized controlled trial of an optimized Option B+ approach. Implement Sci. 2015 Apr 30;10:61. doi: 10.1186/s13012-015-0249-6.

  PMID: 25924668 DERIVED

Study Officials

• Rachel Chapman, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: February 25, 2015
• Study Start: April 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

MO (1)