Effects of engaging fathers and bundling parenting and nutrition interventions on early child development and maternal and paternal parenting in Mara, Tanzania: a factorial cluster-randomized controlled trial.

BACKGROUND: Multicomponent interventions are needed to address the various co-occurring risks that compromise early child nutrition and development. We compared the independent and combined effects of engaging fathers and bundling parenting components into a nutrition intervention on early child development (ECD) and parenting outcomes. METHODS: We conducted a 2×2 factorial cluster-randomized controlled trial across 80 villages in Mara Region, Tanzania, also known as EFFECTS (Engaging Fathers for Effective Child Nutrition and Development in Tanzania; ClinicalTrials.gov, NCT03759821). Households with children under 18 months of age residing with their mother and father were enrolled. Villages were randomly assigned to one of five groups: a nutrition intervention for mothers, a nutrition intervention for couples, a bundled nutrition and parenting intervention for mothers, a bundled intervention for couples, and a standard-of-care control. Interventions were delivered by trained community health workers through peer groups and home visits over 12 months. Mothers, fathers, and children were assessed at baseline, midline, and endline or postintervention. We used a difference-in-difference approach with intention-to-treat analysis to estimate intervention effects on ECD (Bayley Scales of Infant and Toddler Development, third edition) and maternal and paternal parenting and psychosocial well-being. RESULTS: Between October 29, 2018, and May 24, 2019, 960 households were enrolled (n = 192 per arm). Compared to nutrition interventions, bundled interventions improved children's cognitive (ß = .18 [95% CI: 0.01, 0.36]) and receptive language development (ß = .23 [0.04, 0.41]). There were no differences between interventions for other ECD domains. Compared to nutrition interventions, bundled interventions achieved additional benefits on maternal stimulation (ß = .21 [0.04, 0.38]) and availability of home learning materials (ß = .25 [0.07-0.43]) and reduced paternal parenting distress (ß = -.34 [-0.55, -0.12]). Compared to interventions with mothers only, interventions that engaged fathers improved paternal stimulation (ß = .45 [0.27, 0.63]). CONCLUSIONS: Jointly bundling parenting components into nutrition interventions while also engaging both mothers and fathers is most effective for improving maternal and paternal parenting and ECD outcomes.

Effects of engaging fathers and bundling nutrition and parenting interventions on household gender equality and women's empowerment in rural Tanzania: Results from EFFECTS, a five-arm cluster-randomized controlled trial.

Advancing gender equality and women's empowerment (GE/WE) may contribute to better child nutrition and development in low-resource settings. However, few empirical studies have generated evidence on GE/WE and examined the potential of engaging men to transform gender norms and power relations in the context of nutrition and parenting programs. We tested the independent and combined effects of engaging couples and bundling nutrition and parenting interventions on GE/WE in Mara, Tanzania. EFFECTS (ClinicalTrials.gov, NCT03759821) was a cluster-randomized 2 × 2 factorial trial plus control. Eighty village clusters were randomly assigned to one of five intervention conditions: standard of care, mothers nutrition, couples nutrition, mothers bundled nutrition and parenting, or couples bundled nutrition and parenting. Between October 2018-May 2019, 960 households were enrolled with children under 18 months of age residing with their mother and father. Community health workers (CHWs) delivered a bi-weekly 24-session hybrid peer group/home visit gender-transformative behavior change program to either mothers or couples. GE/WE outcomes were analyzed as intention-to-treat and included time use, gender attitudes, social support, couples' communication frequency and quality, decision-making power, intimate partner violence (IPV), and women's dietary diversity (WDD). Data were collected from 957 to 815 mothers and 913 and 733 fathers at baseline and endline, respectively. Engaging couples compared to mothers only significantly increased paternal and maternal gender-equitable attitudes, paternal time spent on domestic chores, and maternal decision-making power. Bundling increased maternal leisure time, decreased maternal exposure to any IPV, and increased WDD over 7 days. A combination of engaging couples and bundling was most effective for paternal gender attitudes, couples communication frequency, and WDD over 24 h and 7 days. Our findings generate novel evidence that CHWs can deliver bundled nutrition and parenting interventions to couples in low-resource community settings that advance GE/WE more than nutrition interventions targeting only women.

Using the PMTCT Cascade to Accelerate Achievement of the Global Plan Goals.

BACKGROUND: Development of country plans for prevention of mother-to-child HIV transmission (PMTCT), including expansion of comprehensive, integrated services, was key to Global Plan achievements. APPROACHES: Use of the PMTCT cascade, an evolving series of sequential steps needed to maximize the health of women and HIV-free survival of infants, was critical for development and implementation of PMTCT plans. Regular review of cascade data at national/subnational levels was a tool for evidence-based decision making, identifying areas of greatest need at each level, and targeting program interventions to address specific gaps. Resulting improvements in PMTCT service delivery contributed to success. Populating the cascade highlighted limitations in data availability and quality that focused attention on improving national health information systems. LIMITATIONS: Use of aggregate, cross-sectional data in the PMTCT cascade presents challenges in settings with high mobility and weak systems to track women and children across services. Poor postnatal follow-up and losses at each step of the cascade have limited use of the cascade approach to measure maternal and child health outcomes beyond the early postnatal period. LESSONS LEARNED: A cascade approach was an effective means for countries to measure progress, identify suboptimal performance areas, and be held accountable for progress toward achievement of Global Plan goals. Using the cascade requires investment of time and effort to identify the type, source, and quality of data needed as programs evolve. Ongoing review of cascade data, with interventions to address discontinuities in the continuum of care, can translate across health areas to improve health care quality and outcomes.

Lessons learned from the PMTCT program in Swaziland: challenges with accepting lifelong ART for pregnant and lactating women - a qualitative study.

BACKGROUND: Swaziland has one of the highest HIV prevalence rates in sub-Saharan Africa, 26 % of the adult population is infected with HIV. The prevalence is highest among pregnant women, at 41.1 %. According to Swaziland's prevention of mother-to-child transmission (PMTCT) guidelines, approximately 50 % of pregnant women are eligible for antiretroviral therapy (ART) by CD4 criteria (<350 cells/ml). Studies have shown that most mother-to-child transmission and postnatal deaths occur among women who are eligible for ART. Therefore, ensuring that ART eligible women are initiated on ART is critical for PMTCT and for mother and baby survival. This study provides insight into the challenges of lifelong ART initiation among pregnant women under Option A in Swaziland. We believe that these challenges and lessons learned from initiating women on lifelong ART under Option A are relevant and important to consider during implementation of Option B+. METHODS: HIV-positive, treatment-eligible, postpartum women and nurses were recruited within maternal and child health (MCH) units using convenience and purposive sampling. Participants came from both urban and rural areas. Focus group discussions (FGDs) and structured interviews using a short answer questionnaire were conducted to gain an understanding of the challenges experienced when initiating lifelong ART. Seven FGDs (of 5-11 participants) were conducted, four FGDs with nurses, two FGDs with women who initiated ART, and one FGD with women who did not initiate ART. A total of 83 interviews were conducted; 50 with women who initiated ART and 33 with women who did not initiate. Data collection with the women was conducted in the local language of SiSwati and data collection with the nurses was done in English. FGDs were audio-recorded and simultaneously transcribed and translated into English. Analysis was conducted using thematic analysis. Transcripts were coded by two researchers in the qualitative software program MAXqda v.10. Thematic findings were illustrated using verbatim quotes which were selected on the basis of being representative of a specific theme. The short-answer interview questionnaire included specific questions about the different steps in the woman's experience initiating ART; therefore the responses for each question were analyzed separately. RESULTS: Findings from the study highlight women feeling overwhelmed by the lifetime commitment of ART, feeling "healthy" when asked to initiate ART, preference for short-course prophylaxis and fear of side effects (body changes). Also, the preference for nurses to determine on an individual basis the number of counseling appointments a woman needs before initiating ART, more information about HIV and ART needed at the community level, and the need to educate men about HIV and ART. CONCLUSION: Women face a myriad of challenges initiating lifelong ART. Understanding women's concerns will aid in developing effective counseling messages, designing appropriate counseling structures, understanding where additional support is needed in the process of initiating ART, and knowing who to target for community level messages.

Evaluating the effectiveness of selected community-level interventions on key maternal, child health, and prevention of mother-to-child transmission of HIV outcomes in three countries (the ACCLAIM Project): a study protocol for a randomized controlled trial.

BACKGROUND: Efforts to scale up and improve programs for prevention of mother-to-child transmission of HIV (PMTCT) have focused primarily at the health facility level, and limited attention has been paid to defining an effective set of community interventions to improve demand and uptake of services and retention. Many barriers to PMTCT are also barriers to pregnancy, childbirth, and postnatal care faced by mothers regardless of HIV status. Demand for maternal and child health (MCH) and PMTCT services can be limited by critical social, cultural, and structural barriers. Yet, rigorous evaluation has shown limited evidence of effectiveness of multilevel community-wide interventions aimed at improving MCH and HIV outcomes for pregnant women living with HIV. We propose to assess the effect of a package of multilevel community interventions: a social learning and action component, community dialogues, and peer-led discussion groups, on the demand for, uptake of, and retention of HIV positive pregnant/postpartum women in MCH/PMTCT services. METHODS/DESIGN: This study will undertake a three-arm randomized trial in Swaziland, Uganda, and Zimbabwe. Districts/regions (n = 9) with 45 PMTCT-implementing health facilities and their catchment areas (populations 7,300-27,500) will be randomly allocated to three intervention arms: 1) community leader engagement, 2) community leader engagement with community days, or 3) community leader engagement with community days and male and female community peer groups. The primary study outcome is HIV exposed infants (HEIs) returning to the health facility within 2 months for early infant diagnosis (EID) of HIV. Secondary study outcomes include gestational age of women attending for first antenatal care, male partners tested for HIV, and HEIs receiving nevirapine prophylaxis at birth. Changes in community knowledge, attitudes, practices, and beliefs on MCH/PMTCT will be assessed through household surveys. DISCUSSION: Implementation of the protocol necessitated changes in the original study design. We purposively selected facilities in the districts/regions though originally the study clusters were to be randomly selected. Lifelong antiretroviral therapy for all HIV positive pregnant and lactating women, Option B+, was implemented in the three countries during the study period, with the potential for a differential impact by study arm. Implementation however, was rapidly done across the districts/regions, so that there is unlikely be this potential confounding. We developed a system of monitoring and documentation of potential confounding activities or actions, and these data will be incorporated into analyses at the conclusion of the project. Strengthens of the study are that it tests multilevel interventions, utilizes program as well as study specific and individual data, and it is conducted under "real conditions" leading to more robust findings. Limitations of the protocol include the lack of a true control arm and inadequate control for the potential effect of Option B+, such as the intensification of messages as the importance of early ANC and male partner testing. TRIAL REGISTRATION: ClinicalTrials.gov (study ID: NCT01971710) Protocol version 5, 30 July 2013, registered 13 August 2013.

Lessons learned from early implementation of option B+: the Elizabeth Glaser Pediatric AIDS Foundation experience in 11 African countries.

BACKGROUND: "Option B+" is a World Health Organization-recommended approach to prevent mother-to-child HIV transmission whereby all HIV-positive pregnant and lactating women initiate lifelong antiretroviral therapy (ART). This review of early Option B+ implementation experience is intended to inform Ministries of Health and others involved in implementing Option B+. METHODS: This implementation science study analyzed data from 11 African countries supported by the Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) to describe early experience implementing Option B+. Data are from 4 sources: (1) national guidelines for prevention of mother-to-child HIV transmission and Option B+ implementation plans, (2) aggregated service delivery data between January 2013 and March 2014 from EGPAF-supported sites, (3) field visits to Option B+ implementation sites, and (4) relevant EGPAF research, quality improvement, and evaluation studies. RESULTS: Rapid adoption of Option B+ led to large increases in percentage of HIV-positive pregnant women accessing ART in antenatal care. By the end of 2013, most programs reached at least 50% of HIV-positive women in antenatal care with ART, even in countries using a phased approach to implementation. Scaling up Option B+ through integrating ART in maternal and child health settings has required expansion of the workforce, and task shifting to allow nurse-led ART initiation has created staffing pressure on lower-level cadres for counseling and community follow-up. Complex data collection needs may be impairing data quality. DISCUSSION: Early experiences with Option B+ implementation demonstrate promise. Continued program evaluation is needed, as is specific attention to counseling and support around initiation of lifetime ART in the context of pregnancy and lactation.

Improved detection of incident HIV infection and uptake of PMTCT services in labor and delivery in a high HIV prevalence setting.

OBJECTIVE: To maximize prevention of mother-to-child transmission of HIV (PMTCT) effectiveness and increase identification of HIV status in maternity units in Swaziland. DESIGN: With a quasi-experimental design, 3 maternity units were randomly assigned to the training intervention and 3 units were controls. METHODS: Targeted on-site training was provided to nurse-midwives in intervention sites. HIV status was recorded with testing offered to women presenting with unknown and distant negative status. Cord blood was obtained and tested for HIV antibodies and presence of nevirapine as a marker of PMTCT intervention coverage. Contingency tables and χ² tests were used to test for associations between frequencies of events. RESULTS: Of the 2444 enrolled women, 215 (9%) arrived in maternity with unknown status and 1398 (58%) had tested HIV negative in antenatal clinic. Significantly more HIV-negative women (45%) and women with unknown status (96%) in intervention sites were tested compared with similar women in control sites, 14% and 65%, respectively (P < 0.0001 for both). Nevirapine coverage in HIV-positive cord blood was significantly higher in intervention sites (80%) than in control sites (69%, P < 0.0001). Cumulative HIV incidence was 4% with an incidence rate of 16.8 per 100 person-years. Antiretroviral prophylaxis coverage in seroconverters was significantly higher in intervention sites 54% (13 of 24) than the control group [26% (9 of 34), P = 0.03]. CONCLUSIONS: In high HIV prevalence settings, such as Swaziland, the incidence of HIV during pregnancy is high. An on-site training intervention for maternity nurses significantly increases the identification of HIV infection and maximizes the provision of PMTCT interventions.