Early ART initiation among HIV-positive pregnant women in central Mozambique: a stepped wedge randomized controlled trial of an optimized Option B+ approach

Abstract

BackgroundDespite effective prevention strategies and increasing investments in global health, maternal to child transmission (MTCT) of HIV remains a significant problem globally, especially in sub-Saharan Africa. In 2012, there were 94,000 HIV-positive pregnant women in Mozambique. Approximately 15% of these women transmitted HIV to their newborn infants, resulting in nearly 14,000 new pediatric HIV infections that year. To address this issue, in 2013, the Mozambican Ministry of Health implemented the World Health Organization-recommended “Option B+” strategy in which all newly diagnosed HIV-positive pregnant women are counseled to initiate combination anti-retroviral therapy (ART) immediately upon diagnosis regardless of CD4 count and to continue treatment for life. Given the limited experience with Option B+ in sub-Saharan Africa, few rigorous pragmatic trials have studied this new treatment strategy.MethodsThis study utilizes an initial formative research process involving patient and health care provider interviews and focus groups, workforce assessments, value stream mapping, and commodity utilization assessments to understand the strengths and weaknesses in the current Option B+ care cascade. The formative research is intended to guide identification and prioritization of key workflow modifications and the development of an enhanced adherence and retention package. These two components are bundled into a defined intervention implemented and evaluated across six health facilities utilizing a stepped wedge randomized controlled trial study design. The overall objective of this trial is to develop and test a pilot intervention in central Mozambique to implement the new Option B+ guidelines with high fidelity and increase the proportion of HIV-positive pregnant women in target antenatal clinics (ANC) who start ART prior to delivery and are retained in care.DiscussionThis pragmatic study utilizes research strategies that have the potential to meaningfully improve the Option B+ care cascade in central Mozambique and to decrease the MTCT of HIV. This trial is designed to identify critical low-cost improvement strategies that can be bundled into a defined intervention. If this intervention has a measurable impact, it can be rapidly scaled up to other ANC in Mozambique and sub-Saharan Africa.Trial registrationClinicalTrials.gov: NCT02371265.

Sexual Practices, Fertility Intentions, and Awareness to Prevent Mother-to-Child Transmission of HIV Among Infected Pregnant Women at the Yaounde Central Hospital

“…Therefore, we concluded that sexual desire and fertility intentions are reversibly inhibited soon after the HIV diagnosis and reappear according to sociodemographic factors and initiation of ART in infected women. The positive impact of ART on fertility intentions in PLHIV has been reported in different studies 7, 14, 39…”

Retention in Care among HIV-Infected Pregnant Women in Haiti with PMTCT Option B

“…Pregnancy itself has been shown to be associated with poor retention in care in several countries [ 3 , 14 , 20 , 21 ]. One study in Malawi with early rollout of universal ART under Option B+ documented improved retention at 6 months postpartum (83%) although additional, larger retention studies in the era of Option B+ are ongoing [ 22 – 24 ]. The single factor associated with LFU in our multivariate analysis was never starting ART.…”

Option B+ in Mozambique: Formative Research Findings for the Design of a Facility-Level Clustered Randomized Controlled Trial to Improve ART Retention in Antenatal Care

“…26 The intervention was implemented in 6 high-volume health centers providing PMTCT and ART services in the Mozambican National Health System. These health centers serve communities along the highly populated Beira highway and railway transport corridor that passes through Sofala and Manica provinces, from the port city of Beira on the Indian Ocean to the Zimbabwe border.…”