A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa

Manasi Soni,Geoffrey Setswe,Stephen M. Weiss,Maria Luisa Alcaide,Deborah L. Jones,Ryan Cook,Violeta J. Rodriguez,Tae Kyoung Lee,Karl Peltzer

doi:10.1186/s12981-017-0187-2

Abstract

BackgroundWe evaluate the impact of clinic-based PMTCT community support by trained lay health workers in addition to standard clinical care on PMTCT infant outcomes.MethodsIn a cluster randomized controlled trial, twelve community health centers (CHCs) in Mpumalanga Province, South Africa, were randomized to have pregnant women living with HIV receive either: a standard care (SC) condition plus time-equivalent attention-control on disease prevention (SC; 6 CHCs; n = 357), or an enhanced intervention (EI) condition of SC PMTCT plus the “Protect Your Family” intervention (EI; 6 CHCs; n = 342). HIV-infected pregnant women in the SC attended four antenatal and two postnatal video sessions and those in the EI, four antenatal and two postnatal PMTCT plus “Protect Your Family” sessions led by trained lay health workers. Maternal PMTCT and HIV knowledge were assessed. Infant HIV status at 6 weeks postnatal was drawn from clinic PCR records; at 12 months, HIV status was assessed by study administered DNA PCR. Maternal adherence was assessed by dried blood spot at 32 weeks, and infant adherence was assessed by maternal report at 6 weeks. The impact of the EI was ascertained on primary outcomes (infant HIV status at 6 weeks and 12 months and ART adherence for mothers and infants), and secondary outcomes (HIV and PMTCT knowledge and HIV transmission related behaviours). A series of logistic regression and latent growth curve models were developed to test the impact of the intervention on study outcomes.ResultsIn all, 699 women living with HIV were recruited during pregnancy (8–24 weeks), and assessments were completed at baseline, at 32 weeks pregnant (61.7%), and at 6 weeks (47.6%), 6 months (50.6%) and 12 months (59.5%) postnatally. Infants were tested for HIV at 6 weeks and 12 months, 73.5% living infants were tested at 6 weeks and 56.7% at 12 months. There were no significant differences between SC and EI on infant HIV status at 6 weeks and at 12 months, and no differences in maternal adherence at 32 weeks, reported infant adherence at 6 weeks, or PMTCT and HIV knowledge by study condition over time.ConclusionThe enhanced intervention administered by trained lay health workers did not have any salutary impact on HIV infant status, ART adherence, HIV and PMTCT knowledge.Trial registration clinicaltrials.gov: number NCT02085356

Highlights

We evaluate the impact of clinic-based prevention of mother-to-child-transmission (PMTCT) community support by trained lay health workers in addition to standard clinical care on PMTCT infant outcomes
The enhanced intervention administered by trained lay health workers did not have any salutary impact on human immunodeficiency virus (HIV) infant status, antiretroviral therapy (ART) adherence, HIV and PMTCT knowledge
Participants in community health centers were randomized into six enhanced intervention (EI) community health centers, and six standard care (SC) CHCs, using the clinic as a unit of randomization for 342 participants in the EI condition, and 357 participants in the SC condition (Fig. 1)

Summary

Introduction

We evaluate the impact of clinic-based PMTCT community support by trained lay health workers in addition to standard clinical care on PMTCT infant outcomes. In the latest National Antenatal Sentinel HIV Prevalence Survey (2013) among women 15–49 years the national HIV prevalence was 29.7%, and in Mpumalanga province 37.5% [5]. These high rates of HIV in rural areas often been attributed to supply and staff shortages, as well as to limited access to care [6]. For the prevention of mother-to-child-transmission (PMTCT) of HIV, the World Health Organization (WHO) proposes that all pregnant women, regardless of CD4 count, be given ART for life (Option B+ ART policy), a policy that was adopted by South Africa in 2015. Risk factors associated with MTCT include low HIV knowledge, nonadherence to ART, lower education, HIV stigma, psychological repercussions of being diagnosed with HIV [10], lack of male partner support, and low medication infant dosing [10, 11]

Objectives

Methods

Results

Discussion

Conclusion