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

Study Overview
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Brief Summary
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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.

Detailed Description
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For over 10 years, services to prevent maternal to child HIV-1 transmission (PMTCT) have been scaled-up and integrated into antenatal care (ANC) in the national health system across Mozambique. In 2004, scale-up of anti-retroviral treatment (ART) also began in Mozambique and is now provided at hundreds of health units. In 2010, the World Health Organization developed new treatment guidelines, termed Option B that emphasized early initiation of ART in antenatal care for all HIV-positive pregnant women. In 2012, the WHO issued a programmatic update endorsing a third option termed Option B+ in which HIV positive pregnant women initiate ART during pregnancy regardless of disease progression and continue treatment for life. The new Option B+ approach has been adopted by the Ministry of Health (MoH) in Mozambique and is in the early phases of implementation. As in many African settings, numerous health system factors present major challenges to successful adoption of the guidelines. In Mozambique, ANC and HIV testing coverage is high but there is substantial loss-to-follow-up (LTFU) at successive stages in the treatment cascade, limited counseling for women and many barriers to actively tracking those women lost to follow-up. Early Ministry of Health data suggests significant challenges remain for long-term adherence for women started on ART via the new Option B+ framework in Manica and Sofala provinces and throughout Mozambique. The successful implementation of new WHO guidelines therefore requires major streamlining of links among ANC, PMTCT, and ART services. The overall objective of this study is to develop and test a pilot intervention in central Mozambique to implement the new WHO guidelines, and increase the proportion of HIV-positive pregnant women in target ANC clinics who start ART prior to delivery, without reducing ART adherence in the first 3 months of therapy. The intervention will emphasize a WHO defined Option B+ approach; HIV-positive mothers will be referred for ART at the time they receive a positive HIV test result in their first ANC visit. The project utilizes an innovative formative research process, which has already been completed, and a stepped wedge implementation science design to evaluate the intervention. The entire study is being conducted in close collaboration with the Center for Operations Research in Beira (known by its Portuguese acronym as CIOB) that is one of three research centers in Mozambique managed by the MOH National Institute of Health (the research arm of the MoH).

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

Conditions
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HIV

Intervention / Treatment
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* Other: Adherence and retention package


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women who test HIV-positive in antenatal care services at target health facilities Exclusion Criteria: Pregnant women who arrived at health facilities who already have tested positive HIV-positive pregnant women who cannot start ART

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adherence and retention intervention<br>Implementation of adherence and retention package | Other: Adherence and retention package<br>* 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.<br>|
| No Intervention: Control<br>Clusters continue without intervention package | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Mozambique, antenatal care, adherence, retention, pregnancy, HIV-positive mothers retained in ART after 90 days