Integration of HIV Prevention With Sexual and Reproductive Health Services: Evidence for Contraceptive Options and HIV Outcomes Study Experience of Integrating Oral Pre-exposure HIV Prophylaxis in Family Planning Services in Lusaka, Zambia.

The WHO guideline on the integration of family planning (FP) and pre-exposure HIV prophylaxis (PrEP) to enhance the health of women and adolescent girls is reflected in the Zambia Consolidated Guidelines for Treatment and Prevention of HIV Infection, 2020. There is however a dearth of data on the integration of PrEP and FP in Zambia. We describe the integration of oral PrEP in FP services using the Evidence for Contraceptive Options and HIV Outcomes (ECHO) study experience at Kamwala District Health Center in Lusaka, Zambia. The provision of oral PrEP at Kamwala started in October 2017, lasting for ~11 months, and utilized the model where initial processes to offer PrEP were on-site followed by off-site referral to laboratory and PrEP provider services. The characteristics of 658 women who enrolled in ECHO at Kamwala are representative of women accessing FP services in Lusaka. About 644 of the enrollees were offered oral PrEP. The proportion of women accepting PrEP was low at 1.08% and the proportion of study visits at which PrEP was requested was also low at 0.57%. Those who accepted PrEP were above 20 years old, married, with at least primary education, sexual behavior, and risk comparable to decliners. The ECHO study experience indicates that the setup and integration of oral PrEP and FP services are feasible in the setting. However, uptake of PrEP was very low. Possible contributory factors were as follows: (1) timing of introduction of PrEP midway in the study, (2) PrEP being a new intervention, (3) challenges of autonomy of young women to include a daily pill into their lives and anticipated challenges to adherence because of fear of adverse events, (4) possible underdetermined risk due to use of an unvalidated risk assessment tool and assessment by health care provider vs. self-assessment, and (5) extra layer of challenges to negotiate due to needing for off-site referrals. Following these findings, we conclude that further research through demonstration projects of integration of oral PrEP and FP may provide solutions to low uptake. This information is critical for scaling up of integration HIV prevention services and sexual and reproductive health (SRH) services.

A Community-Designed Play-Yard Intervention to Prevent Microbial Ingestion: A Baby Water, Sanitation, and Hygiene Pilot Study in Rural Zambia.

Malnourished children in low-income contexts usually suffer from environmental enteric dysfunction, which is damage to the intestines caused by chronic exposure to bacterial pathogens from feces hypothesized to contribute to stunting. Many intervention studies are piloting "Baby water, sanitation, and hygiene (WASH)" to help rural farming families reduce infant and young children's (IYC's) exposure to human and free-range livestock feces. One proposed Baby WASH intervention is a play-yard, which consists of a baby-proofed structure (i.e., playpen) that caregivers can place IYC into while doing chores around the household yard. This article describes the pilot development and assessment of a community-built Baby WASH play-yard and a plastic play-yard intervention with 21 caregivers of 6- to 24-month-old IYC in rural Zambia. A modified Trials of Improved Practices approach was used to conduct three visits in each household: an introductory visit during which play-yard use was explained, a second visit consisting of a semi-structured interview and a session of behavioral counseling, and a final visit which included a 2-hour observation of play-yard use. The second and final visits also included 24-hour recalls, and all three visits included spot observations of play-yard use. Reports from caregivers suggest that the community-built play-yard protected IYC from ingesting soil and livestock feces. Barriers to intervention use included caregivers' WASH beliefs and practices, community reactions, and play-yard maintenance. More work is needed to examine the role of women's time use in their home environment, community reactions to the intervention, and the biological efficacy to reduce microbial ingestion.

Characterizing Potential Risks of Fecal-Oral Microbial Transmission for Infants and Young Children in Rural Zambia.

Undernourished children in low-income contexts often suffer from environmental enteric disorder-damage to the intestines probably caused by chronic exposure to bacterial pathogens from feces. We aimed to identify strategies for reducing infants and young children's (IYC) exposure to human and animal feces in rural farming families by conducting direct observation of 30 caregiver-infant dyads for 143 hours and recording water, sanitation, and hygiene (WASH)-related behaviors to identify possible pathways of fecal-oral transmission of bacteria among IYC in rural Zambia. In addition to mouthing visibly dirty hands, toys, sibling's body parts, and food, 14 IYC actively ingested 6.1 ± 2.5 (mean ± standard deviation [SD]) pieces of soil and stones and one ingested animal feces 6.0 ± 0 times in the span of 5 hours. Ninety-three percent (21 of 30) of mothers reported observing the index-child eating soil and 17% (5 of 30) of mothers reported observing the index-child eating chicken feces. Adult and child handwashing was uncommon, and even though 70% (28 of 30) of households had access to a latrine, human feces were found in 67% of homestead yards. Most animals present in the household were un-corralled, and the highest observable counts of feces came from chickens, pigs, and cattle. To protect IYC in low-income communities from the exploratory ingestion of feces and soil, Baby WASH interventions will need to interrupt fecal-oral microbial transmission vectors specific to IYC with a focus on feasibility, caregiver practices, and local perceptions of risk.

Fostering community understanding of sufficient benefit and early stopping for a phase 2B HIV prevention clinical trial in Africa.

BACKGROUND: Most trials of interventions are designed to address the traditional null hypothesis of no benefit. VOICE, a phase 2B HIV prevention trial funded by NIH and conducted in Africa, is designed to assess if the intervention will prevent a substantial fraction of infections. Planned interim analysis may provide conclusive evidence against the traditional null hypothesis without establishing substantial benefit. At this interim point, the Data and Safety Monitoring Board would then face the dilemma of knowing the product has some positive effect, but perhaps not as great an effect as the protocol has declared necessary. PURPOSE: In March 2008, NIH program staff recommended that the VOICE protocol team discuss the stopping rules with stakeholders prior to initiating the protocol. The goals of the workshop were to inform community representatives about the potential ethical dilemma associated with stopping rules and engage in dialogue about these issues. We describe the resulting community consultation and summarize the outcomes. METHODS: A 2-day workshop was convened with the goal of having a clear and transparent consultation with the stakeholders around the question, 'Given emerging evidence that a product could prevent some infections, would the community support a decision to continue accruing to the trial?' Participants included research staff and community stakeholders. Lectures with visual aids, discussions, and exercises using interactive learning tasks were used, with a focus on statistics and interpreting data from trials, particularly interim data. RESULTS: Results of oral and written evaluations by participants were reviewed. The feedback was mostly positive, with some residual confusion regarding statistical concepts. However, discussions with attendees later revealed that not all felt prepared to engage fully in the workshop. LIMITATIONS: This was the presenters' first experience facilitating a formal discussion with an audience that had no advanced science, research, or mathematics training. Community representatives' concern regarding speaking for their communities without consulting them also created a challenge for the workshop. CONCLUSIONS: Open discussion around trial stopping rules requires that all discussants have an understanding of trial design concepts and feel a sense of empowerment to ask and answer questions. The VOICE CWG workshop was a first step toward the goal of open discussion regarding trial stopping rules and interim results for the study; however, ongoing education and dialogue must occur to ensure that all stakeholders fully participate in the process.