Provider experiences with three- and six-month antiretroviral therapy dispensing for stable clients in Zambia.

Multi-month dispensing of antiretroviral therapy (ART) has been taken to scale in many settings in sub-Saharan Africa with the benefits of improved client satisfaction and decreased client costs. Six-month ART dispensing may further increase these benefits; however, data are lacking. Within a cluster-randomized trial of three- versus six-month dispensing in Malawi and Zambia, we performed a sub-study to explore Zambian provider experiences with multi-month dispensing. We conducted 18 in-depth interviews with clinical officers and nurses dispensing ART as part of INTERVAL in Zambia. Interview questions focused on provider perceptions of client acceptability, views on client sharing and selling of ART, and perceptions on provider workload and clinic efficiency, with a focus on differences between three- and six-month dispensing. Interviews were analyzed using inductive thematic analysis to identify key themes and patterns within the data. Providers perceived significant benefits of multi-month dispensing, with advantages of six-month over three-month dispensing related to a reduced burden on clients, and for reductions in their own workload and clinic congestion. Among nearly all providers, the six-month dispensing strategy was perceived as ideal. Further research is needed to quantify clinical outcomes of six-month dispensing and feasibility of scaling-up this intervention in resource-limited settings.Clinical Trial Number: NCT03101592.

Exploring community participation in project design: application of the community conversation approach to improve maternal and newborn health in Zambia.

BACKGROUND: The United Nations Development Programme (UNDP) has adopted an approach entitled Community Conversation (CC) to improve community engagement in addressing health challenges. CCs are based on Paulo Freire's transformative communication approach, in which communities pose problems and critically examine their everyday life experiences through discussion. We adopted this approach to engage communities in maternal and newborn health discussions in three rural districts of Zambia, with the aim of developing community-generated interventions. METHODS: Sixty (60) CCs were held in three target districts, covering a total of 20 health facilities. Communities were purposively selected in each district to capture a range of rural and peri-urban areas at varying distances from health facilities. Conversations were held four times in each community between May and September 2014. All conversations were digitally recorded and later transcribed. NVivo version 10 was used for data analysis. RESULTS AND DISCUSSION: The major barriers to accessing maternal health services included geography, limited infrastructure, lack of knowledge, shortage of human resources and essential commodities, and insufficient involvement of male partners. From the demand side, a lack of information and misconceptions, and, from the supply side, inadequately trained health workers with poor attitudes, negatively affected access to maternal health services in target districts either directly or indirectly. At least 17 of 20 communities suggested solutions to these challenges, including targeted community sensitisation on the importance of safe motherhood, family planning and prevention of teenage pregnancy. Community members and key stakeholders committed time and resources to address these challenges with minimal external support. CONCLUSION: We successfully applied the CC approach to explore maternal health challenges in three rural districts of Zambia. CCs functioned as an advocacy platform to facilitate direct engagement with key decision makers within the community and to align priorities while incorporating community views. There was a general lack of knowledge about safe motherhood and family planning in all three districts. However, other problems were unique to health facilities, demonstrating the need for tailored interventions.

Community-based delivery of HIV treatment in Zambia: costs and outcomes.

OBJECTIVE: The aim is to determine the total annual cost per patient treated and total cost per patient retained on antiretroviral therapy in Zambia in conventional care in facilities and across community-based differentiated service delivery (DSD) models. DESIGN: Economic evaluation was conducted using retrospective electronic record review.Twenty healthcare facilities (13 with DSD models and 7 as comparison sites) in six of Zambia's 10 provinces were considered. METHODS: All individuals on antiretroviral therapy (ART) >18 years old at the study sites were enrolled in a DSD model or conventional care by site type, respectively, with at least 12 months of follow-up data. Accessing care through DSD models [community adherence groups (CAGs), urban adherence groups (UAGs), home ART delivery and care, and mobile ART services] or facility-based conventional care with 3-monthly visits. Total annual cost per patient treated and the annual cost per patient retained in care 12 months after model enrolment. Retention in care was defined as attending a clinic visit at 12 months ± 3 months. RESULTS: The DSD models assessed cost more per patient/year than conventional care. Costs ranged from an annual $116 to $199 for the DSD models, compared with $100 for conventional care. CAGs and UAGs increased retention by 2 and 14%, respectively. All DSD models cost more per patient retained at 12 months than conventional care. The CAG had the lowest cost/patient retained for DSD models ($140-157). CONCLUSIONS: Although they achieve equal or improved retention in care, out-of-facility models of ART were more expensive than conventional care.

Multimonth dispensing of up to 6 months of antiretroviral therapy in Malawi and Zambia (INTERVAL): a cluster-randomised, non-blinded, non-inferiority trial.

BACKGROUND: Facility-based, multimonth dispensing of antiretroviral therapy (ART) for HIV could reduce burdens on patients and providers and improve retention in care. We assessed whether 6-monthly ART dispensing was non-inferior to standard of care and 3-monthly ART dispensing. METHODS: We did a pragmatic, cluster-randomised, unblinded, non-inferiority trial (INTERVAL) at 30 health facilities in Malawi and Zambia. Eligible participants were aged 18 years or older, HIV-positive, and were clinically stable on ART. Before randomisation, health facilities (clusters) were matched on the basis of country, ART cohort size, facility type (ie, hospital vs health centre), and region or province. Matched clusters were randomly allocated (1:1:1) to standard of care, 3-monthly ART dispensing, or 6-monthly ART dispensing using a simple random allocation sequence. The primary outcome was retention in care at 12 months, defined as the proportion of patients with less than 60 consecutive days without ART during study follow-up, analysed by intention to treat. A 2·5% margin was used to assess non-inferiority. This study is registered with ClinicalTrials.gov, NCT03101592. FINDINGS: Between May 15, 2017, and April 30, 2018, 9118 participants were randomly assigned, of whom 8719 participants (n=3012, standard of care group; n=2726, 3-monthly ART dispensing group; n=2981, 6-monthly ART dispensing group) had primary outcome data available at 12 months and were included in the primary analysis. The median age of participants was 42·7 years (IQR 36·1-49·9) and 5774 (66·2%) of 8719 were women. The primary outcome was met by 2478 (82·3%) of 3012 participants in the standard of care group, 2356 (86·4%) of 2726 participants in the 3-monthly ART dispensing group, and 2729 (91·5%) of 2981 participants in the 6-monthly ART dispensing group. After adjusting for clustering, for retention in care at 12 months, the 6-monthly ART dispensing group was non-inferior to the standard of care group (percentage-point increase 9·1 [95% CI 0·9-17·2]) and to the 3-monthly ART dispensing group (5·0% [1·0-9·1]). INTERPRETATION: Clinical visits with ART dispensing every 6 months was non-inferior to standard of care and 3-monthly ART dispensing. 6-monthly ART dispensing is a promising strategy for the expansion of ART provision and achievement of HIV treatment targets in resource-constrained settings. FUNDING: US Agency for International Development.

Eligibility for differentiated models of HIV treatment service delivery: an estimate from Malawi and Zambia.

BACKGROUND: Little is known about the proportion of HIV-positive clients on antiretroviral therapy (ART) who meet stability criteria for differentiated service delivery (DSD) models. We report the proportion of ART clients meeting stability criteria as part of screening for a randomized trial of multimonth dispensing in Malawi and Zambia. METHODS: For a DSD trial now underway, we screened HIV-positive clients aged at least 18 years presenting for HIV treatment in 30 adult ART clinics in Malawi and Zambia to determine eligibility for DSD. Stability was defined as on first-line ART (efavirenz/tenofovir/lamivudine) for at least 6 months, no ART side effects, no toxicity or infectious complications, no noncommunicable diseases being treated in ART clinic, no lapses in ART adherence in the prior 6 months (>30 days without taking ART), and if female, not pregnant or breastfeeding. RESULTS: In total, 3465 adult ART clients were approached between 10 May 2017 and 30 April 2018 (Malawi: 1680; Zambia: 1785). Of the 2938 who answered screening questions (Malawi: 1527; Zambia: 1411), 2173 (73.5%) met criteria for DSD eligibility (Malawi: 72.8%; Zambia: 74.3%). The most common reasons for ineligibility were being on ART less than 6 months (9.6%) and a regimen other than standard first-line (7.9%). CONCLUSION: Approximately three-quarters of all adult clients presenting at ART clinics in Malawi and Zambia were eligible for DSD using a typical definition of stability. High uptake of DSD models by eligible clients would have a major impact on the infrastructure and the allocation of HIV treatment resources.

Multiple behaviour change intervention for diarrhoea control in Lusaka, Zambia: a cluster randomised trial.

BACKGROUND: Effective prevention and control of diarrhoea requires caregivers to comply with a suite of proven measures, including exclusive breastfeeding, handwashing with soap, correct use of oral rehydration salts, and zinc administration. We aimed to assess the effect of a novel behaviour change intervention using emotional drivers on caregiver practice of these behaviours. METHODS: We did a cluster randomised controlled trial in Lusaka Province, Zambia. A random sample of 16 health centres (clusters) were selected from a sampling frame of 81 health centres in three of four districts in Lusaka Province using a computerised random number generator. Each cluster was randomly assigned 1:1 to either the intervention-clinic events, community events, and radio messaging-or to a standard care control arm, both for 6 months. Primary outcomes were exclusive breastfeeding (self-report), handwashing with soap (observation), oral rehydration salt solution preparation (demonstration), and zinc use in diarrhoea treatment (self-report). We measured outcome behaviours at baseline before start of intervention and 4-6 weeks post-intervention through repeat cross-sectional surveys with mothers of an infant younger than 6 months and primary caregivers of a child younger than 5 years with recent diarrhoea. We compared outcomes on an intention-to-treat population between intervention and control groups adjusted for baseline behaviour. The study was registered with ClinicalTrials.gov, number NCT02081521. FINDINGS: Between Jan 20 and Feb 3, 2014, we recruited 306 mothers of an infant aged 0-5 months (156 intervention, 150 standard care) and 343 primary caregiver of a child aged 0-59 months with recent diarrhoea (176 intervention, 167 standard care) at baseline. Between Oct 20 to Nov 7, 2014, we recruited 401 mothers of an infant 0-5 months (234 intervention, 167 standard care) and 410 primary caregivers of a child 0-59 months with recent diarrhoea (257 intervention, 163 standard care) at endline. Intervention was associated with increased prevalence of self-reported exclusive breastfeeding of infants aged 0-5 months (adjusted difference 10·5%, 95% CI 0·9-19·9). Other primary outcomes were not affected by intervention. Cluster intervention exposure ranged from 11-81%, measured by participant self-report with verification questions. Comparison of control and intervention clusters with coverage greater than 35% provided strong evidence of an intervention effect on oral rehydration salt solution preparation and breastfeeding outcomes. INTERPRETATION: The intervention may have improved exclusive breastfeeding (assessed by self-reporting), but intervention effects were diluted in clusters with low exposure. Complex caregiver practices can improve through interventions built around human motives, but these must be implemented more intensely. FUNDING: Absolute Return for Kids (ARK) and Comic Relief.