Protocol for an evaluation of the initiation of an integrated longitudinal outpatient care model for severe chronic non-communicable diseases (PEN-Plus) at secondary care facilities (district hospitals) in 10 lower-income countries.

INTRODUCTION: The Package of Essential Noncommunicable Disease Interventions-Plus (PEN-Plus) is a strategy decentralising care for severe non-communicable diseases (NCDs) including type 1 diabetes, rheumatic heart disease and sickle cell disease, to increase access to care. In the PEN-Plus model, mid-level clinicians in intermediary facilities in low and lower middle income countries are trained to provide integrated care for conditions where services traditionally were only available at tertiary referral facilities. For the upcoming phase of activities, 18 first-level hospitals in 9 countries and 1 state in India were selected for PEN-Plus expansion and will treat a variety of severe NCDs. Over 3 years, the countries and state are expected to: (1) establish PEN-Plus clinics in one or two district hospitals, (2) support these clinics to mature into training sites in preparation for national or state-level scale-up, and (3) work with the national or state-level stakeholders to describe, measure and advocate for PEN-Plus to support development of a national operational plan for scale-up. METHODS AND ANALYSIS: Guided by Proctor outcomes for implementation research, we are conducting a mixed-method evaluation consisting of 10 components to understand outcomes in clinical implementation, training and policy development. Data will be collected through a mix of quantitative surveys, routine reporting, routine clinical data and qualitative interviews. ETHICS AND DISSEMINATION: This protocol has been considered exempt or covered by central and local institutional review boards. Findings will be disseminated throughout the project's course, including through quarterly M&E discussions, semiannual formative assessments, dashboard mapping of progress, quarterly newsletters, regular feedback loops with national stakeholders and publication in peer-reviewed journals.

An assessment of the Zimbabwe ministry of health and child welfare provider initiated HIV testing and counselling programme.

BACKGROUND: Provider-initiated HIV testing and counselling (PITC) is widely recommended to ensure timely treatment of HIV. The Zimbabwe Ministry of Health introduced PITC in 2007. We aimed to evaluate institutional capacity to implement PITC and investigate patient and health care worker (HCW) perceptions of the PITC programme. METHODS: Purposive selection of health care institutions was conducted among those providing PITC. Study procedures included 1) assessment of implementation procedures and institutional capacity using a semi-structured questionnaire; 2) in-depth interviews with patients who had been offered HIV testing to explore perceptions of PITC, 3) Focus group discussions with HCW to explore views on PITC. Qualitative data was analysed according to Framework Analysis. RESULTS: Sixteen health care institutions were selected (two central, two provincial, six district hospitals; and six primary care clinics). All institutions at least offered PITC in part. The main challenges which prevented optimum implementation were shortages of staff trained in PITC, HIV rapid testing and counselling; shortages of appropriate counselling space, and, at the time of assessment, shortages of HIV test kits. Both health care workers and patients embraced PITC because they had noticed that it had saved lives through early detection and treatment of HIV. Although health care workers reported an increase in workload as a result of PITC, they felt this was offset by the reduced number of HIV-related admissions and satisfaction of working with healthier clients. CONCLUSION: PITC has been embraced by patients and health care workers as a life-saving intervention. There is need to address shortages in material, human and structural resources to ensure optimum implementation.

Applying the RE-AIM framework in a process evaluation of the introduction of the Non-Pneumatic Anti-Shock Garment in a rural district of Zimbabwe.

The Non-Pneumatic Anti-Shock Garment (NASG) is a first aid tool that can halt and reverse hypovolemic shock secondary to obstetric hemorrhage. The World Health Organization recommended the NASG for use as a temporizing measure in 2012, but uptake of the recommendation has been slow, partially because operational experience is limited. The study is a process evaluation of the introduction of NASG in a public sector health facility network in rural Zimbabwe utilizing an adapted RE-AIM, categorizing observations into the domains of: reach, effectiveness, adoption, implementation and maintenance. The location of the study was Hurungwe district, where staff members of 34 health facilities at primary (31), secondary (2) and tertiary (1) levels of care participated. We found that all facilities became skilled in using the NASG, and that the NASG was used in 10 of 11 instances of severe hemorrhage. In the cases of hypovolemic shock where the NASG was used, there were no maternal deaths and no extreme adverse outcomes related to obstetric hemorrhage in the study period. Among the 10 NASG uses, the garment was used correctly in each case. Fidelity to processes was high, especially in regard to training and cascading skills, but revisions of the NASG rotation and replacement operating procedures were required to keep clean garments stocked. Clinical documentation was also a key challenge. NASG introduction dovetailed very well with pre-existing systems for obstetric emergency response, and improved clinical outcomes. Scale-up of the NASG in the Zimbabwean public health system can be undertaken with careful attention to mentorship, drills, documentation and logistics.

Feasibility and impact of near-point-of-care integrated tuberculosis/HIV testing in Malawi and Zimbabwe.

OBJECTIVES: Near-point-of-care (POC) testing for early infant diagnosis (EID) and viral load expedites clinical action and improves outcomes but requires capital investment. We assessed whether excess capacity on existing near-POC devices used for TB diagnosis could be leveraged to increase near-POC HIV molecular testing, termed integrated testing, without compromising TB services. DESIGN: Preimplementation/postimplementation studies in 10 health facilities in Malawi and 8 in Zimbabwe. METHODS: Timeliness of EID and viral load test results and clinical action were compared between centralized and near-POC testing using Somers' D tests (continuous indicators) and risk ratios (RR, binary indicators); TB testing/treatment rates and timeliness were analyzed preintegration/postintegration. RESULTS: With integration, average device utilization increased but did not exceed 55%. Despite the addition of HIV testing, TB test volumes, timeliness, and treatment initiations were maintained. Although few HIV-positive infants were identified, near-POC EID testing improved treatment initiation within 1 month by 57% compared with centralized EID [Malawi RR: 1.57, 95% confidence interval (CI) 0.98-2.52], and near-POC viral load testing significantly increased the proportion of patients with elevated viral load receiving clinical action within 1 month (Zimbabwe RR: 5.26, 95% CI 3.38-8.20; Malawi RR: 3.90, 95% CI 2.58-5.91). CONCLUSION: Integrating TB/HIV testing using existing multidisease platforms is feasible and enables increased access to rapid diagnostics without disrupting existing TB services. Our results serve as an example of a novel, efficient implementation model that can increase access to critical testing services across disease silos and should be considered for additional clinical applications.

Retention-in-care in the PMTCT cascade: definitions matter! Analyses from the INSPIRE projects in Malawi, Nigeria and Zimbabwe.

INTRODUCTION: Definitions of retention-in-care in Prevention of Mother-to-Child Transmission of HIV (PMTCT) vary substantially between studies and programmes. Some definitions are based on visits missed/made, others on a minimum total number of visits, or attendance at a final clinic visit at a specific time. An agreed definition could contribute to developing evidence-based interventions for improving retention-in-care. In this paper, we estimated retention-in-care rates according to different definitions, and we quantified and visualized the degree of agreement between definitions. METHODS: We calculated retention in care rates using nine definitions in the six INSPIRE PMTCT intervention studies, conducted in three sub-Saharan African countries between 2013 and 2017. With data from one of the studies (E4E), we estimated the agreement between definitions using Gwet's agreement coefficient (AC1) and concordance. We calculated positive predictive values (PPV) and negative predictive values (NPV) for all definitions considering successively each definition as the reference standard. Finally, we used a Multiple Correspondence Analysis (MCA) to examine clustering of the way different definitions handle retention-in-care. RESULTS: Retention-in-care rates among 5107 women ranged from 30% to 76% in the complete dataset with Gwet's AC1 being 0.56 [0.53; 0.59] indicating a moderate agreement between all definitions together. Two pairs of definitions with high inner concordance and agreement had either very high PPV or very high NPV, and appeared distinct from the other five definitions on the MCA figures. These pairs of definitions were also the ones resulting in the lowest and highest estimates of retention-in-care. The simplest definition, that only required a final clinic visit to classify women as retained in care, and classified 55% of women as retained in care, had a PPV ranging from 0.7 to 1 and a NPV ranging from 0.69 to 0.98 when excluding the two pairs afore-mentioned; it resulted in a moderate to substantial agreement and a 70% to 90% concordance with all other definitions. CONCLUSIONS: Our study highlights the variability of definitions in estimating retention-in-care. Some definitions are very stringent which may be required in some instances. A simple indicator such as attendance at a single time point may be sufficient for programme planning and evaluation.

Key barriers and enablers associated with uptake and continuation of oral pre-exposure prophylaxis (PrEP) in the public sector in Zimbabwe: Qualitative perspectives of general population clients at high risk for HIV.

BACKGROUND: Understanding the perspectives and preferences of clients eligible for pre-exposure prophylaxis (PrEP) is essential to designing programs that meet clients' needs. To date, most PrEP programs in limited-resource settings have been implemented by partner organizations for specific target populations, but the government of Zimbabwe aims to make PrEP available to the broader population at substantial risk in public sector clinics. However, there is limited information on general population perspectives about PrEP in Zimbabwe. METHODS: A qualitative study was conducted to explore clients' motivation to take or decline PrEP and continue or discontinue PrEP. Through a PrEP pilot in one urban family planning clinic and one rural youth center in Zimbabwe, 150 HIV-negative clients screened as being at high risk of HIV and were offered PrEP between January and June 2018. Sixty semi-structured interviews were conducted with clients who agreed to follow-up (including 5 decliners, all from the rural youth center, and 55 accepters, with 42 from the rural youth center and 13 from the urban family planning clinic). Interviews were conducted after either the first or second PrEP follow-up appointment or after the client declined PrEP. Interviews were audio recorded, de-identified, transcribed, and coded thematically. RESULTS: PrEP uptake was driven by risk perception for HIV, and in many cases, that risk was introduced by the unsafe behavior or HIV-positive status of a partner. Among sero-discordant couples (SDCs), the desire to safely conceive a child was also cited as a factor in taking PrEP. Clients who opted for PrEP preferred it to other forms of HIV prevention. SDCs reported decreased condom use after PrEP initiation and in some cases were using PrEP while trying to conceive a child. After initiating PrEP, clients had more confidence in their sexual relationships and less stress associated with negotiating condom use. Family and partner support was critical to starting and continuing PrEP, but some clients stopped PrEP or missed appointments due to side effects or logistical challenges such as transportation. CONCLUSIONS: Results of this study can be used to provide operational guidance for national public sector roll-out of PrEP as part of combination HIV prevention in Zimbabwe. Based on feedback and experiences of clients, the training materials for health workers can be refined to ensure that health workers are prepared to counsel clients on the decision to start and/or continue PrEP and answer common client questions. Program advertisements should also be targeted with key messages that speak to client experiences. TRIAL REGISTRATION: Clinical Trial Registry Number: PACTR201710002651160.

Impact of Point-of-Care CD4 Testing on Retention in Care Among HIV-Positive Pregnant and Breastfeeding Women in the Context of Option B+ in Zimbabwe: A Cluster Randomized Controlled Trial.

INTRODUCTION: Scale-up of Option B+ in Zimbabwe has increased antiretroviral therapy (ART) coverage but patient loss-to-follow-up remains high; thus, effective strategies to improve retention in care are needed. Evidence for Elimination, a cluster randomized controlled trial, evaluated the impact of point-of-care (POC) CD4 testing with CD4 count-specific adherence counseling on rates of retention among 1150 HIV-positive pregnant women initiating ART in Zimbabwe. METHODS: Thirty-two primary care health facilities were randomized to offer either standard-of-care (SOC) or POC CD4 testing plus CD4-specific counseling to clients (POC Plus). The primary outcome was the proportion of HIV-positive pregnant women retained on ART after 12 months, calculated by cluster-adjusted proportions, unadjusted and adjusted relative risks (RR and aRR, respectively). RESULTS: Retention in care 12 months after initiation was 50.7% and 54.5% in the POC Plus and SOC arms, respectively (RR 0.93, 95% confidence interval [CI]: 0.78 to 1.11; aRR 0.91, 95% CI: 0.77 to 1.07). Although considered not retained, 9.7% transferred to another facility and 0.2% died. Most women, 95.3% in POC Plus and 92.9% in SOC, initiated ART within 1 month of antenatal booking (RR 1.03, 95% CI: 0.97 to 1.08). DISCUSSION: Although patient retention was similar in both arms, women in the POC Plus arm were more likely to have received a CD4 test at booking and a repeat CD4 test later in care. CD4 is no longer required for treatment initiation but is still recommended in national guidelines and is of value in clinical management. Further work is needed to identify effective strategies to increase patient retention in ART care.

Patterns of HIV Care Clinic Attendance and Adherence to Antiretroviral Therapy Among Pregnant and Breastfeeding Women Living With HIV in the Context of Option B+ in Zimbabwe.

BACKGROUND: Consistent use of antiretroviral therapy (ART) during pregnancy and breastfeeding reduces the likelihood of mother-to-child HIV transmission. All pregnant and breastfeeding women living with HIV in Zimbabwe are offered ART with same-day initiation regardless of CD4 count (Option B+). We investigated patterns of clinic attendance and adherence to ART among HIV-infected pregnant women in Zimbabwe. METHODS: The Evidence for Elimination cluster-randomized trial evaluating point-of-care CD4 testing included 1150 HIV-infected ART-naive women attending antenatal care between January 2014 and June 2015. Thirty-two primary care facilities were randomized between 2 arms. In this secondary analysis of Evidence for Elimination data collected from routine clinic records, we classified women by number of pills dispensed, and estimated adherence from the ratio of pills to days since ART initiation (Medication Possession Ratio, adherent if ≥95%) or the period when they stopped receiving medication. RESULTS: Two-thirds (67.7%) were still receiving medication 1 year after initiation; less than half of the cohort (39.1%) were adherent. Younger women, newly diagnosed with HIV, and/or first presenting to antenatal care in their third trimester were more likely to drop from care or be nonadherent 360 days after ART initiation. CONCLUSION: Adherence to ART is suboptimal particularly among young, newly diagnosed, and/or late presenting patients. Interventions that target these groups, as well as provide additional support to all women who are newly diagnosed, may improve Option B+ ART care. More information is needed about the barriers to ART care among late presenters and teenagers.

Modeling the Impact of Retention Interventions on Mother-to-Child Transmission of HIV: Results From INSPIRE Studies in Malawi, Nigeria, and Zimbabwe.

BACKGROUND: Six implementation research studies in Malawi, Nigeria, and Zimbabwe tested approaches for improving retention in care among women living with HIV. We simulated the impact of their interventions on the probability of HIV transmission during pregnancy and breastfeeding. METHODS: A computer-based state-transition model was developed to estimate the impact of the retention interventions. Patient-level data from the 6 studies were aggregated and analyzed, and weighted averages of mother-to-child transmission (MTCT) of HIV probabilities were presented. The average MTCT probability of the more successful interventions was applied to national estimates to calculate potential infections averted if these interventions were taken to scale. RESULTS: Among the total cohort of 5742 HIV-positive women, almost 80% of all infant infections are attributed to the roughly 20% of HIV-positive pregnant and breastfeeding women not retained on antiretroviral therapy. Higher retention in the arms receiving interventions resulted in an overall lower estimated MTCT probability of 9.9% compared with 12.3% in the control arms. In the 2 studies that showed a statistically significant effect, Prevention of MTCT Uptake and Retention (PURE) and Mother Mentor (MoMent), the difference in transmission rates between intervention and control arms was 4.1% and 7.3%, respectively. Scaling up retention interventions nationally in the 3 countries could avert an average of almost 3000 infant infections annually. CONCLUSIONS: Linking HIV-positive pregnant women to antiretroviral therapy and retaining them is essential for addressing the remaining gaps and challenges in HIV/AIDS care and the elimination of MTCT. At national level, even modest improvements in retention translates into large numbers of infant infections averted.

Does provision of point-of-care CD4 technology and early knowledge of CD4 levels affect early initiation and retention on antiretroviral treatment in HIV-positive pregnant women in the context of Option B+ for PMTCT?

Evidence for Elimination (E4E) is a collaborative project established in 2012 as part of the INSPIRE (INtegrating and Scaling up PMTCT through Implementation REsearch) initiative. E4E is a cluster-randomized trial with 2 arms; Standard of care and "POC Plus" [in which point-of-care (POC) CD4 devices and related counseling support are provided]; aimed at improving retention-in-care of HIV-infected pregnant women and mothers. In November 2013, Zimbabwe adopted Option B+ for HIV-positive pregnant women under which antiretroviral treatment eligibility is no longer based on CD4 count. However, Ministry of Health and Child Care guidelines still require baseline and 6-monthly CD4 testing for treatment monitoring, until viral load testing becomes widely available. Considering the current limited capacity for viral-load testing, the significant investments in CD4 testing already made and the historical reliance on CD4 by health care workers for determining eligibility for antiretroviral treatment, E4E seeks to compare the impact of the provision of POC CD4 technology and early knowledge of CD4 levels on retention-in-care at 12 months, with the current standard of routine, laboratory-based CD4 testing. The study also compares rates of initiation and time-to-initiation between the 2 arms and according to level of maternal CD4 count, the cost of retaining HIV-positive pregnant women in care and the acceptability and feasibility of POC CD4 in the context of Option B+. Outcome measures are derived from routine health systems data. E4E will provide data on POC CD4 testing and retention-in-care associated with Option B+ and serve as an early learning platform to inform implementation of Option B+ in Zimbabwe.

Evaluation of the PIMA point-of-care CD4 analyzer in VCT clinics in Zimbabwe.

Point-of-care (POC) CD4 testing was implemented at a stand-alone HIV voluntary testing and counseling centre in Harare, Zimbabwe. To validate the use of this new technology, paired blood samples were collected from 165 patients either by a nurse or a laboratory technician and tested using POC and conventional laboratory CD4 machines. Finger prick (capillary) blood was collected directly into the PIMA POC CD4 Analyzer cartridges and tested immediately, whereas venous blood collected into evacuated tubes was used for CD4 enumeration on a Becton Dickinson FACSCalibur. There was no significant difference in mean absolute CD4 counts between the POC PIMA and Becton Dickinson FACSCalibur platforms (+7.6 cells/microL; P = 0.72). Additionally, there was no significant difference in CD4 counts between the platforms when run by either a nurse (+18.0 cells/microL; P = 0.49), or a laboratory technicians (-3.1 cells/microL; P = 0.93). This study demonstrates that POC CD4 testing can be conducted in a voluntary testing and counseling setting for staging HIV-positive clients. Both nurses and laboratory technicians performed the test accurately, thereby increasing the human resources available for POC CD4 testing. By producing same-day results, POC CD4 facilitates immediate decision-making, patient management and referral and may help improve patient care and retention. POC CD4 may also alleviate testing burdens at traditional central CD4 laboratories, hence improving test access in both rural and urban environments.