Clinical trial NCT02371265: Early ART Initiation Among HIV-positive Pregnant Women in Central Mozambique
Official title: Early ART Initiation Among HIV-positive Pregnant Women in Central Mozambique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Keywords: HIV
Mozambique
antenatal care
adherence
retention
pregnancy
HIV-positive mothers retained in ART after 90 days
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Health Alliance International
name: Beira Operations Research Center, Mozambique Ministry of Health
First posted: 2015-02-25
Enrollment: 761
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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).

Eligibility criteria: 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

Primary outcomes:
measure: Retention at 30 days
timeFrame: 45 days
measure: Adherence at 90 days
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beira
country: Mozambique
facility: Beira Operations Research Center
state: Sofala
Study officials:
affiliation: University of Washington
name: Rachel Chapman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.