The SENTINEL study of differentiated service delivery models for HIV treatment in Malawi, South Africa, and Zambia: research protocol for a prospective cohort study.

BACKGROUND: Many countries in sub-Saharan Africa are rapidly scaling up "differentiated service delivery" (DSD) models for HIV treatment to improve the quality of care, increase access, reduce costs, and support the continued expansion and sustainability of antiretroviral therapy (ART) programs. Although there is some published evidence about the health outcomes of patients in DSD models, little is known about their impacts on healthcare providers' job satisfaction, patients' quality of life, costs to providers or patients, or how DSD models affect resource allocation at the facility level. METHODS: SENTINEL is a multi-year observational study that will collect detailed data about DSD models for ART delivery and related services from 12 healthcare facilities in Malawi, 24 in South Africa, and 12 in Zambia. The first round of SENTINEL included a patient survey, provider survey, provider time-and-motion observations, and facility resource use inventory. A survey of clients testing for HIV and a supplement to the facility resource use component to describe service delivery integration will be added for the second round. The patient survey will ask up to 10 patients enrolled in each DSD model at each study site about their experiences in HIV care and in DSD models, costs incurred seeking treatment, and preferences for HIV service delivery. The provider survey will ask up to 10 providers per site about the impact of DSD models on their positions and clinics. The time-and-motion component will directly observe the time use of a sample of providers implementing DSD models. Finally, the resource utilization component will collect facility-level data about DSD model availability and enrollment and the human and other resources needed to implement them. SENTINEL is planned to include four or more approximately annual rounds of data collection between 2021 and 2026. DISCUSSION: As national DSD programs for HIV treatment mature, it is important to understand how individual healthcare facilities are interpreting and implementing national guidelines and how healthcare workers and clients are adapting to new models of service delivery. SENTINEL will help policy makers and program managers understand the benefits and costs of differentiated service delivery and improve resource allocation going forward.

Receipt of infant HIV DNA PCR test results is associated with a reduction in retention of HIV-exposed infants in integrated HIV care and healthcare services: a quantitative sub-study nested within a cluster randomised trial in rural Malawi.

BACKGROUND: Retention of HIV-infected mothers in integrated HIV and healthcare facilities is effective at reducing mother-to-child-transmission (MTCT) of HIV. In the context of Option B+, we examined maternal and HIV-exposed infant retention across three study arms to 18 months postpartum: mother-and-infant clinics (MIP), MIP with short-messaging service (MIP + SMS) and standard of care (SOC). In particular, we focused on the impact of mothers receiving an infant's HIV PCR test result on maternal and infant study retention. METHODS: A quantitative sub-study nested within a cluster randomised trial undertaken between May 2013 and August 2016 across 30 healthcare facilities in rural Malawi enrolling HIV-infected pregnant mothers and HIV-exposed infants on delivery, was performed. Survival probabilities of maternal and HIV-exposed infant study retention was estimated using Kaplan-Meier curves. Associations between mother's receiving an infant's HIV test result and in particular, an infant's HIV-positive result on maternal and infant study retention were modelled using time-varying multivariate Cox regression. RESULTS: Four hundred sixty-one, 493, and 396 HIV-infected women and 386, 399, and 300 HIV-exposed infants were enrolled across study arms; MIP, MIP + SMS and SOC, respectively. A total of 47.5% of mothers received their infant's HIV test results < 5 months postpartum. Receiving an infant's HIV result by mothers was associated with a 70% increase in infant non-retention in the study compared with not receiving an infant's result (HR = 1.70; P-value< 0.001). Receiving a HIV-positive result was associated with 3.12 times reduced infant retention compared with a HIV-negative result (P-value< 0.001). Of the infants with a HIV-negative test result, 87% were breastfed at their final study follow-up. CONCLUSIONS: Receiving an infant's HIV test result was a driving factor for reduced infant study retention, especially an infant's HIV-positive test result. As most HIV-negative infants were still breastfed at their last follow-up, this indicates a large proportion of HIV-exposed infants were potentially at future risk of MTCT of HIV via breastfeeding but were unlikely to undergo follow-up HIV testing after breastfeeding cessation. Future studies to identify and address underlying factors associated with infant HIV testing and reduced infant retention could potentially improve infant retention in HIV/healthcare facilities. TRIAL REGISTRATION: Pan African Clinical Trial Registry: PACTR201312000678196 .

Human papillomavirus testing using existing nucleic acid testing platforms to screen women for cervical cancer: implementation studies from five sub-Saharan African countries.

OBJECTIVES: To demonstrate acceptability and operational feasibility of introducing human papillomavirus (HPV) testing as a principal cervical cancer screening method in public health programmes in sub-Saharan Africa. SETTING: 45 primary and secondary health clinics in Malawi, Nigeria, Senegal, Uganda and Zimbabwe. PARTICIPANTS: 15 766 women aged 25-54 years presenting at outpatient departments (Senegal only, general population) or at antiretroviral therapy clinics (all other countries, HIV-positive women only). Eligibility criteria followed national guidelines for cervical cancer screening. INTERVENTIONS: HPV testing was offered to eligible women as a primary screening for cervical cancer, and HPV-positive women were referred for visual inspection with acetic acid (VIA), and if lesions identified, received treatment or referral. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcomes were the proportion of HPV-positive women who received results and linked to VIA and the proportion of HPV-positive and VIA-positive women who received treatment. RESULTS: A total of 15 766 women were screened and tested for HPV, among whom 14 564 (92%) had valid results and 4710/14 564 (32%) were HPV positive. 13 837 (95%) of valid results were returned to the clinic and 3376 (72%) of HPV-positive women received results. Of women receiving VIA (n=2735), 715 (26%) were VIA-positive and 622 (87%) received treatment, 75% on the same day as VIA. CONCLUSIONS: HPV testing was found to be feasible across the five study countries in a public health setting, although attrition was seen at several key points in the cascade of care, namely results return to women and linkage to VIA. Once women received VIA, if eligible, the availability of on-site cryotherapy and thermal ablation allowed for same-day treatment. With sufficient resources and supportive infrastructure to ensure linkage to treatment, use of HPV testing for cervical cancer screening as recommended by WHO is a promising model in low-income and middle-income countries.

Differentiated Service Delivery Models for HIV Treatment in Malawi, South Africa, and Zambia: A Landscape Analysis.

INTRODUCTION: Many countries in Africa are scaling up differentiated service delivery (DSD) models for HIV treatment, but most existing data systems do not describe the models in use. We surveyed organizations that were supporting DSD models in 2019 in Malawi, South Africa, and Zambia to describe the diversity of DSD models being implemented at that time. METHODS: We interviewed DSD model implementing organizations for descriptive information about each of the organization's models of care. We described the key characteristics of each model, including population of patients served, location of service delivery, frequency of interactions with patients, duration of dispensing, and cadre(s) of provider involved. To facilitate analysis, we refer to 1 organization supporting 1 model of care as an "organization-model." RESULTS: The 34 respondents (8 in Malawi, 16 in South Africa, 10 in Zambia) interviewed described a total of 110 organization-models, which included 19 facility-based individual models, 21 out-of-facility-based individual models, 14 health care worker-led groups, and 3 client-led groups; jointly, these encompassed 12 specific service delivery strategies, such as multimonth dispensing, adherence clubs, home delivery, and changes to facility hours. Over two-thirds (n=78) of the organization-models were limited to clinically stable patients. Almost all organization-models (n=96) continued to provide clinical care at established health care facilities; medication pickup took place at facilities, external pickup points, and adherence clubs. Required numbers of provider interactions per year varied widely, from 2 to 12. Dispensing intervals were typically 3 or 6 months in Malawi and Zambia and 2 months in South Africa. Individual models relied more on clinical staff, while group models made greater use of lay personnel. CONCLUSIONS: As of 2019, there was a large variety of differentiated service models being offered for HIV treatment in Malawi, South Africa, and Zambia, serving diverse patient populations.

Impact of Mother-Infant Pair Clinics and Short-Text Messaging Service (SMS) Reminders on Retention of HIV-Infected Women and HIV-Exposed Infants in eMTCT Care in Malawi: A Cluster Randomized Trial.

BACKGROUND: Poor retention of mothers and HIV-exposed infants (HEIs) in HIV care threatens efforts to eliminate pediatric HIV. Novel strategies are required to address this challenge. We compared 12-month maternal and HEI postpartum retention in health facilities implementing the following HIV care delivery models: integrated HIV and maternal, neonatal, and child health services [mother-infant pair (MIP) clinics], MIP clinics plus short-text messaging service (SMS) reminders to prevent default (MIP + SMS), and standard of care (SOC). METHODS: From May 2013 to August 2016, a cluster randomized trial was conducted in rural Malawi, which randomized 30 health facilities to the 3 service delivery models. HIV+ pregnant women and HEIs were enrolled and followed up to monitor compliance with prescheduled visits and retention. Log binomial regression, using generalized estimated equation, was used to assess the impact of the models on retention. RESULTS: The trial enrolled 461, 493, and 396 HIV+ pregnant women and 386, 399, and 300 HEIs into the MIP, MIP + SMS, and SOC arms, respectively. Compared with the 12-month maternal retention rate in the SOC arm (22.2%), the rates were similar in the MIP arm [19.3%, risk ratio (RR): 0.85, 95% confidence interval (CI): 0.56 to 1.30] and in the MIP + SMS arm (24.9%, RR: 1.08, 95% CI: 0.87 to 1.35). Compared with the 12-month infant retention rate in the SOC arm (9.8%), the rates were similar in the MIP arm (8.0%, RR: 0.89, 95% CI: 0.31 to 2.58) and in the MIP + SMS arm (19.5%, RR: 1.40, 95% CI: 0.85 to 2.31). CONCLUSIONS: MIP and MIP + SMS service delivery models were ineffective in improving maternal and infant retention in rural Malawi.

Integrating HIV and Maternal, Neonatal and Child Health Services in Rural Malawi: An Evaluation of the Implementation Processes and Challenges.

INTRODUCTION: Introducing Option B+ in Malawi increased antiretroviral therapy coverage among pregnant and breastfeeding women 3 fold. The Promoting Retention among Infants and Mothers Effectively (PRIME) study integrated care of Maternal, Neonatal and Child Health services through a mother-infant pair (MIP) clinic. This article evaluates the implementation processes and challenges health care workers' experienced in implementing these MIP clinics. METHODS: Between May 2013 and August 2016, 20 health facilities implemented MIP clinics. Health care workers' performance implementing MIP clinics was assessed through a mentorship score from 0 to 5 and supplemented with qualitative data from mentorship reports. Visit alignment of participants' appointment and attendance dates with MIP clinic dates were calculated and summarized by overall proportions among all patient visits. RESULTS: The average mentorship score was 3.8, improving from 3.0 to 4.2 from quarter one 2015 to quarter one 2016. Proportions of maternal and infant appointment dates that aligned with MIP clinic dates were 47.0% and 55.9%, with greatest improvement between 2013 and 2015. Proportions of maternal and infant attendance dates that aligned with MIP clinic dates were 41.7% and 51.2% and improved over time. DISCUSSION: Despite improvement in staff mentorship scores, many MIPs were not exposed to integrated HIV and Maternal, Neonatal and Child Health services offered through MIP clinics primarily because of clinic scheduling challenges. To improve utilization of integrated MIP clinics, careful design of a delivery approach is needed that is acceptable to clinic staff, addresses local realities, and includes appropriate investment and oversight.