PMTCT and Implementation and Outcomes of the 2013 WHO Option B+ Guidelines

Protocol Title: Acceptability of Lifelong Treatment (Option B+) among HIV-Positive Pregnant and Lactating Women in Selected Sites in Malawi

About this study: This Dance Marathon at UCLA-funded study aimed to gain an understanding of the acceptability of lifelong ART (Option B+) among pregnant and lactating women in Malawi - where Option B+ has been implemented since 2011 - to identify areas for improvement in HIV/health service delivery. The study staff conducted in-depth interviews and focus group discussions among eligible women (over the age of 18, pregnant or breastfeeding, and HIV-positive) and HIV service health workers (working in either antenatal settings or ART clinics) from four clinics in Malawi between September and December 2013 to better understand facilitators and barrier to enrolment in HIV treatment.

Status: Complete

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Protocol Title: The Kabeho Study: Kigali Antiretroviral and Breastfeeding Assessment for the Elimination of HIV (*Kabeho – is a Kinyarwanda word for wishing someone a long life)

About this study: In April 2012, the Government of Rwanda implemented a policy that would allow all HIV-positive women to be initiated on lifelong antiretroviral treatment (ART), known as Option B+. Rwanda also instituted an innovative infant feeding counseling and support program for HIV-positive women in the prevention of mother-to-child HIV transmission (PMTCT) programs.

This study, known as Kabeho, takes advantage of a unique opportunity to both evaluate maternal and child outcomes in Rwanda Option B+ program.  The primary objective of this four-year study is to determine the 24-month HIV-free survival in a cohort of children born to approximately 600 HIV-positive pregnant women in 14 high volume antenatal clinics in Kigali, Rwanda, that are participating in the Rwanda National PMTCT program. Additional objectives include determining the individual- and facility-level factors associated with: 1) healthy infant nutritional outcomes (as defined by lack of stunting, underweight, or wasting) in the cohort of HIV-exposed children and 2) adherence to the Option B+ ART regimen among pregnant/postpartum women and their HIV-exposed children; and to document birth outcomes in the cohort of study infants exposed to triple drug ART regimens in utero.

The study utilizes a prospective observational cohort design and collects individual and facility data through a mixed methods approach with both quantitative and qualitative data.  In addition, interviews with health care providers and PMTCT program leaders are conducted to assess implementation successes and challenges, and to gather recommendations for program improvement.

Status: This study is ongoing.

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Sub-study: Protocol Title: Antiretroviral Resistance Among Kabeho Study Women
About this sub-study: This study is a Dance Marathon at UCLA-funded analysis of existing laboratory samples from the Kabeho Study. The analysis aims to determine the presence of genotypic ARV resistance in a subset of HIV-infected infant and maternal samples.
Status: This study is ongoing.

View more information and resources on the Kabeho Study.


Protocol Title: Promoting Constructive Male Engagement to Increase Use of PMTCT Services in Kabale District, Uganda

About this study: This study conducted in collaboration with FHI360 on an intervention aimed to engage men in use of PMTCT services and family planning decision making in Kabale, Uganda. The male engagement intervention involved facility- and community-based components designed to support constructive male involvement in a full spectrum of PMTCT services, including family planning (FP). The study employed a quasi-experimental design, with four health centers serving as intervention sites and four serving as comparisons. Pre- and post-intervention cross sectional interviews were conducted with approximately 750 HIV care and treatment clients and a separate survey was conducted with 1,200 men before and after their participation in a study-sponsored workshop. 

Status: Complete

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Protocol Title: The Voices of Positive Mothers Study: An exploratory study of pregnant and lactating women’s perceptions of lifelong ART to prevent HIV transmission during pregnancy, breastfeeding and beyond

About this study: The Government of the Republic of Zambia has adopted elimination of pediatric HIV as a national goal. The country is in the process of implementing the World Health Organization’s 2013 prevention of mother-to-child HIV transmission guidelines, which call for initiation of all HIV-positive pregnant or breastfeeding women on antiretroviral therapy (known as Option B+). Little is known about what HIV-positive women think or feel about antiretroviral therapy during pregnancy, breastfeeding, and potentially for life. For lifelong treatment programs to be successful, HIV-positive women’s voices must be heard. This study, led by EGPAF in collaboration with the Zambian Ministry of Health, sought to explore the acceptability and feasibility of lifelong antiretroviral treatment for PMTCT among HIV-positive pregnant and breastfeeding women in Zambia. The study involved focus group discussions and semi-structured interviews with HIV-positive pregnant and lactating women recruited from two urban and two rural Ministry of Health clinic sites in Zambia.

Status: Complete

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Protocol Title: A secondary analysis of retention across the PMTCT cascade in selected countries

About this Study: This study involved a retrospective records review of HIV-positive pregnant women and HIV-exposed infants who attended health services at select sites in Rwanda, Kenya, Malawi and Swaziland between October 2011 and March 2012. This study set to find out levels of retention among women and children enrolled in PMTCT services. In the analysis, “retention” was measured by rates of program (clinic) attendance as documented in the health facility registers. The study also assessed how retention varied by facility, demographics, presence and type of facility follow-up mechanism, drug adherence among women enrolled in Option A versus Option B/B+ of the WHO recommended PMTCT guidelines, and patient-level factors associated with ART initiation.

Status: Complete


Protocol title: Assessing the feasibility, acceptability, and health services utilization outcomes of the use of Mother-Baby Packs for delivery of antiretroviral drugs to HIV-infected pregnant women and their infants in Lesotho

About this Study: This UNICEF-funded study aimed to assess the acceptability of the Mother-Baby Pack (MBP) in Lesotho, whereby all pregnant woman at their first antenatal care visit were provided with a pack filled with prenatal vitamins and PMTCT medications (if the expectant mother was HIV-positive). This study also aimed to determine the uptake of selected maternal and child health and PMTCT services among women who received MBP versus women who did not. Study staff used a dual design method: a retrospective cohort whereby facility records (from before and after implementation of MBP) of selected sites were reviewed; and a prospective cross-sectional design whereby pregnant and postpartum women, health staff and community workers participated in interviews and focus group discussions.

Status: Complete

Resources Published to Date:


Protocol Title: Measuring PMTCT Program Effectiveness among Women and Infants through Community-based Household Surveys in Lesotho

About this Study: This USAID-funded study aims to determine the population based 18-24 month HIV-free survival among HIV-exposed children in Lesotho. This cross-sectional, community-based evaluation will explore factors associated with child HIV infection, death, or HIV-free survival such as maternal health, health seeking behavior, exposure to PMTCT program, maternal and infant ARV use, and infant feeding practices and others. In addition, information MCH health seeking behavior and child outcomes among HIV negative women will be collected.

Status: This study is expected to begin in mid-2015.


Protocol Title: PMTCT Program Effectiveness among Women and Infants in Lesotho (PEA-WIL Study)

About this Study: This is a USAID-funded study aims to determine the HIV incidence, and HIV transmission and HIV-free survival rate among cohorts of HIV-negative and HIV-positive pregnant women and their infants respectively after implementation of the WHO Option B+ guidelines. The study team will use a prospective cohort design to determine factors associated with HIV infection acquisition, survival and disease progression from ANC to 24 months after delivery in selected sites in three districts in Lesotho. Rates of selected ART toxicity events, adverse birth outcomes, and growth outcomes among the HIV exposed children will be captured and will also be compared with birth and growth outcomes among children of HIV negative women.

Status: The study is ongoing.


Protocol Title: Observational Evaluation of the Implementation of Implementation of option B+ and selected outcomes in two districts in the Southwest and Northwest regions of Cameroon

About this Study: This CDC-funded study aims to measure HIV treatment uptake, retention, adherence and HIV-related mortality in a cohort of HIV-positive women and their infants from  the PMTCT program in 20 health facilities implementing Option B+ in Cameroon. Study staff will follow 600 mother–infant pairs for 18 months after delivery using an observational cohort design.

Status: This study is ongoing.


Protocol Title: Measuring PMTCT Program Effectiveness among Women and Infants through Community-based Household Surveys in Swaziland

About this Study: This USAID-funded study aims to determine the population based 18-24 month HIV-free survival among HIV-exposed children in Swaziland. This cross-sectional, community-based evaluation will explore factors associated with child HIV infection, death, or HIV-free survival such as maternal health, health seeking behavior, exposure to PMTCT program, maternal and infant ARV use, and infant feeding practices and others. In addition, information MCH health seeking behavior and child outcomes among HIV negative women will be collected.

Status: This study is ongoing.


Protocol Title: An Assessment of Operating Procedures to Provide Support and Follow-up for HIV-positive Women Seeking Antenatal Services in Kinshasa, Democratic Republic of Congo

About this Study: The overall aim of this Johnson & Johnson-funded evaluation is to assess early retention of HIV-positive pregnant women attending antenatal services in Kinshasa, Democratic Republic of Congo following the initiation of lifelong antiretroviral treatment. The study involves a comparison between control sites and intervention sites receiving a standard operating procedure on referrals for counseling support and defaulter tracing processes.

Status: This study is ongoing.


Protocol Title: Assessing the cost-effectiveness of using SMS reminders to increase PMTCT and ART retention in Gaza Province

About this Study: This UKAID- and ARK-funded study is assessing the effect of sending SMS text messages on retention of patients living with HIV in PMTCT, pre-ART and ART services in eight districts of Gaza Province in Mozambique. It will evaluate the acceptability of SMS text messages by study participants, as well as the cost-efficiency of its implementation. The study is a prospective, cluster randomized "stepped wedge" trial, with early and late intervention groups.

Status: This study is ongoing.


Protocol Title: Acceptability of Option B+ Among HIV-Positive Pregnant and Breastfeeding Women in Selected Sites in Zimbabwe

About this Study: This qualitative study, funded by the Children’s Investment Fund Foundation, seeks to understand barriers and facilitators to women initiating Option B+ in Zimbabwe.  This study is an adaptation of the Malawi Acceptability study, however in addition to interviewing pregnant and post-partum women on Option B+ and health care workers, this study also interviewed women on Option A who had not yet initiated Option B+.  This additional input provided insight to perspectives in the community among women eligible for Option B+.

Status: Newly initiated.


Protocol Title: Understanding the Barriers and Facilitators to Initiation, Adherence and Retention of Lifelong Treatment Among HIV-Positive Pregnant and Lactating Women in Selected Sites in Cameroon

About this study: This qualitative, CDC-funded study will explore barriers and facilitators that affect a woman’s decision to initiate and adhere to Option B+ treatment regimens in the northwest and southwest regions of Cameroon. This study will also explore the use of peer educators to deliver health care messages and assist in retaining women in care. In-depth interviews and focus group discussions will be conducted with pregnant women, postpartum women, health care workers and peer educators. 

Status: Newly initiated.


Protocol Title: Evaluating the Delivery and Content of Lifelong ART Counseling Messages Provided to Newly Diagnoses HIV-Positive Pregnant and Post-Partum Women in Swaziland

About this Study: This mixed methods, USAID-funded study seeks to evaluate the content and delivery of counseling messages provided to women initiating and receiving ongoing counseling for Option B+ in Swaziland. Data is being collected through observation of post-test counseling, exit interviews with women receiving post-test and ongoing counseling. In-depth interviews with women receiving ongoing counseling and health care workers will also be conducted. This study seeks to evaluate a woman’s understanding of the content provided during counseling as well as her perception about the delivery of counseling messages.  

Status: Newly initiated.