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

Abstract Background 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. Methods In a cluster randomized controlled trial, twelve community health centers (CHCs) in Mpumalanga Province, South Afri...

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Main Authors: Karl Peltzer, Stephen M. Weiss, Manasi Soni, Tae Kyoung Lee, Violeta J. Rodriguez, Ryan Cook, Maria Luisa Alcaide, Geoffrey Setswe, Deborah L. Jones
Format: Article
Language:English
Published: BMC 2017-12-01
Series:AIDS Research and Therapy
Subjects:
Online Access:http://link.springer.com/article/10.1186/s12981-017-0187-2
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author Karl Peltzer
Stephen M. Weiss
Manasi Soni
Tae Kyoung Lee
Violeta J. Rodriguez
Ryan Cook
Maria Luisa Alcaide
Geoffrey Setswe
Deborah L. Jones
author_facet Karl Peltzer
Stephen M. Weiss
Manasi Soni
Tae Kyoung Lee
Violeta J. Rodriguez
Ryan Cook
Maria Luisa Alcaide
Geoffrey Setswe
Deborah L. Jones
author_sort Karl Peltzer
collection DOAJ
description Abstract Background 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. Methods In 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. Results In 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. Conclusion The 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
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spelling doaj.art-ee017fa02a174f0f80530ee6565f92d32022-12-22T03:24:17ZengBMCAIDS Research and Therapy1742-64052017-12-0114111210.1186/s12981-017-0187-2A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South AfricaKarl Peltzer0Stephen M. Weiss1Manasi Soni2Tae Kyoung Lee3Violeta J. Rodriguez4Ryan Cook5Maria Luisa Alcaide6Geoffrey Setswe7Deborah L. Jones8HIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research CouncilDepartment of Psychiatry and Behavioral Sciences, University of Miami Miller School of MedicineDepartment of Psychiatry and Behavioral Sciences, University of Miami Miller School of MedicineDepartment of Public Health Sciences, University of Miami Miller School of MedicineDepartment of Psychiatry and Behavioral Sciences, University of Miami Miller School of MedicineDepartment of Psychiatry and Behavioral Sciences, University of Miami Miller School of MedicineDepartment of Medicine, Infectious Diseases, University of Miami Miller School of MedicineHIV/AIDS/STIs and TB (HAST) Research Programme, Human Sciences Research CouncilDepartment of Psychiatry and Behavioral Sciences, University of Miami Miller School of MedicineAbstract Background 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. Methods In 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. Results In 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. Conclusion The 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 NCT02085356http://link.springer.com/article/10.1186/s12981-017-0187-2Controlled trialBehavioural interventionPrevention of mother to child transmission of HIV (PMTCT)South Africa
spellingShingle Karl Peltzer
Stephen M. Weiss
Manasi Soni
Tae Kyoung Lee
Violeta J. Rodriguez
Ryan Cook
Maria Luisa Alcaide
Geoffrey Setswe
Deborah L. Jones
A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa
AIDS Research and Therapy
Controlled trial
Behavioural intervention
Prevention of mother to child transmission of HIV (PMTCT)
South Africa
title A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa
title_full A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa
title_fullStr A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa
title_full_unstemmed A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa
title_short A cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of HIV (PMTCT) in South Africa
title_sort cluster randomized controlled trial of lay health worker support for prevention of mother to child transmission of hiv pmtct in south africa
topic Controlled trial
Behavioural intervention
Prevention of mother to child transmission of HIV (PMTCT)
South Africa
url http://link.springer.com/article/10.1186/s12981-017-0187-2
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