Community delivery of antiretroviral drugs: A non-inferiority cluster-randomized pragmatic trial in Dar es Salaam, Tanzania.

BACKGROUND: With the increase in people living with HIV in sub-Saharan Africa and expanding eligibility criteria for antiretroviral therapy (ART), there is intense interest in the use of novel delivery models that allow understaffed health systems to successfully deal with an increasing demand for antiretroviral drugs (ARVs). This pragmatic randomized controlled trial in Dar es Salaam, Tanzania, evaluated a novel model of ARV community delivery: lay health workers (home-based carers [HBCs]) deliver ARVs to the homes of patients who are clinically stable on ART, while nurses and physicians deliver standard facility-based care for patients who are clinically unstable. Specifically, the trial aimed to assess whether the ARV community delivery model performed at least equally well in averting virological failure as the standard of care (facility-based care for all ART patients). METHODS AND FINDINGS: The study took place from March 1, 2016, to October 27, 2017. All (48) healthcare facilities in Dar es Salaam that provided ART and had an affiliated team of public-sector HBCs were randomized 1:1 to either (i) ARV community delivery (intervention) or (ii) the standard of care (control). Our prespecified primary endpoint was the proportion of adult non-pregnant ART patients with virological failure at the end of the study period. The prespecified margin of non-inferiority was a risk ratio (RR) of 1.45. The mean follow-up period was 326 days. We obtained intent-to-treat (ITT) RRs using a log-binomial model adjusting standard errors for clustering at the level of the healthcare facility. A total of 2,172 patients were enrolled at intervention (1,163 patients) and control (1,009 patients) facilities. Of the 1,163 patients in the intervention arm, 516 (44.4%) were both clinically stable on ART and opted to receive ARVs in their homes or at another meeting point of their choosing in the community. At the end of the study period, 10.9% (95/872) of patients in the control arm and 9.7% (91/943) in the intervention arm were failing virologically. The ITT RR for virological failure demonstrated non-inferiority of the ARV community delivery model (RR 0.89 [1-sided 95% CI 0.00-1.18]). We observed no significant difference between study arms in self-reported patient healthcare expenditures over the last 6 months before study exit. Of those who received ARVs in the community, 97.2% (95% CI 94.7%-98.7%) reported being either "satisfied" or "very satisfied" with the program. Other than loss to follow-up (18.9% in the intervention and 13.6% in the control arm), the main limitation of this trial was that substantial decongestion of healthcare facilities was not achieved, thus making the logic for our preregistered ITT approach (which includes those ineligible to receive ARVs at home in the intervention sample) less compelling. CONCLUSIONS: In this study, an ARV community delivery model performed at least as well as the standard of care regarding the critical health indicator of virological failure. The intervention did not significantly reduce patient healthcare expenditures, but satisfaction with the program was high and it is likely to save patients time. Policy-makers should consider piloting, evaluating, and scaling more ambitious ARV community delivery programs that can reach higher proportions of ART patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT02711293.

The impact of community health worker-led home delivery of antiretroviral therapy on virological suppression: a non-inferiority cluster-randomized health systems trial in Dar es Salaam, Tanzania.

BACKGROUND: Home delivery of antiretroviral therapy (ART) by community health workers (CHWs) may improve ART retention by reducing the time burden and out-of-pocket expenditures to regularly attend an ART clinic. In addition, ART home delivery may shorten waiting times and improve quality of care for those in facility-based care by decongesting ART clinics. This trial aims to determine whether ART home delivery for patients who are clinically stable on ART combined with facility-based care for those who are not stable on ART is non-inferior to the standard of care (facility-based care for all ART patients) in achieving and maintaining virological suppression. METHODS: This is a non-inferiority cluster-randomized trial set in Dar es Salaam, Tanzania. A cluster is one of 48 healthcare facilities with its surrounding catchment area. 24 clusters were randomized to ART home delivery and 24 to the standard of care. The intervention consists of home visits by CHWs to provide counseling and deliver ART to patients who are stable on ART, while the control is the standard of care (facility-based ART and CHW home visits without ART home delivery). In addition, half of the healthcare facilities in each study arm were randomized to standard counseling during home visits (covering family planning, prevention of HIV transmission, and ART adherence), and half to standard plus nutrition counseling (covering food production and dietary advice). The non-inferiority design applies to the endpoints of the ART home delivery trial; the primary endpoint is the proportion of ART patients at a healthcare facility who are virally suppressed at the end of the study period. The margin of non-inferiority for this primary endpoint was set at nine percentage points. DISCUSSION: As the number of ART patients in sub-Saharan Africa is expected to rise, this trial provides causal evidence on the effectiveness of a home-based care model that could decongest ART clinics and reduce patients' healthcare expenditures. More broadly, this trial will inform the increasing policy interest in task-shifting of chronic disease care from facility- to community-based healthcare workers. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02711293 . Registration date: 16 March 2016.

Preparedness of HIV care and treatment clinics for the management of concomitant non-communicable diseases: a cross-sectional survey.

BACKGROUND: In Sub-Saharan Africa, epidemiological studies have reported an increasing burden of non-communicable diseases (NCD) among people living with HIV. NCD management can be feasibly integrated into HIV care; however, clinic readiness to provide NCD services in these settings should first be assessed and gaps in care identified. METHODS: A cross-sectional survey conducted in July 2013 assessed the resources available for NCD care at 14 HIV clinics in Dar es Salaam, Tanzania. Survey items related to staff training, protocols, and resources for cardiovascular disease risk factor screening, management, and patient education. RESULTS: 43 % of clinics reported treating patients with hypertension; however, only 21 % had a protocol for NCD management. ECHO International Health standards for essential clinical equipment were used to measure clinic readiness; 36 % met the standard for blood pressure cuffs, 14 % for glucometers. Available laboratory tests for NCD included blood glucose (88 %), urine dipsticks (78 %), and lipid panel (57 %). 21 % had a healthcare worker with NCD training. All facilities provided some form of patient education, but only 14 % included diabetes, 57 % tobacco cessation, and 64 % weight management. CONCLUSIONS: A number of gaps were identified in this sample of HIV clinics that currently limit the ability of Tanzanian healthcare workers to diagnose and manage NCD in the context of HIV care. Integrated NCD and HIV care may be successfully achieved in these settings with basic measures incorporated into existing infrastructures at minimal added expense, i.e., improving access to basic functioning equipment, introducing standardized treatment guidelines, and improving healthcare worker education.

Mortality and treatment failure among HIV-infected adults in Dar Es Salaam, Tanzania.

OBJECTIVES: Monitoring antiretroviral treatment (ART) outcomes is essential for assessing the success of HIV care and treatment programs in resource-limited settings (RLS). METHODS: Longitudinal analyses of clinical and immunologic parameters in HIV-infected adults initiated on ART between November 2004 and June 2008 at Management and Development for Health (MDH)-Presidents Emergency Plan For AIDS Relief PEPFAR supported HIV care and treatment clinics in Tanzania. RESULTS: A total of 12 842 patients were analyzed (65.9% female, median baseline CD4 count, 106 cells/mm(3)). Significant improvements in immunologic status were observed with an increase in CD4 count to 298 (interquartile range [IQR] 199-416), 372 (256-490) and 427 (314-580) cells/mm(3), at 1, 2, and 3 years, respectively. Overall mortality was 13.1% (1682 of 12 842). Male sex, World Health Organization (WHO) stage III/IV, CD4 <200 cells/mm(3), hemoglobin (Hgb) <8.5 g/dL, and stavudine (d4T)-containing regimens were independently associated with early and overall mortality. CONCLUSIONS: Closer monitoring of males and patients with advanced HIV disease following ART initiation may improve clinical and immunologic outcomes in these individuals.

Engaging community leaders to improve male partner participation in the prevention of mother-to-child transmission of HIV in Dar es Salaam, Tanzania.

BACKGROUND: Male partner participation improves uptake, retention and outcomes of prevention of mother-to-child transmission of HIV (PMTCT) services. However, in patriarchal settings few men accompany their partners to antenatal care (ANC) and PMTCT services. We explored whether community leaders can improve male partner participation in ANC and PMTCT. METHODS: We integrated initiatives to increase male partner participation in routine ANC care in six health facilities (attending about 4,500 new pregnant women per quarter) in Dar es Salaam, Tanzania in 2015/16. These initiatives were adapted from a best performing health facility, on male partner participation in ANC and PMTCT, referred to as the "best practice site". At the six purposively selected intervention sites, we sensitized and garnered commitment from healthcare providers to provide couple friendly services. We then worked with the providers to sensitize and engage community leaders to integrate and promote male partner participation initiatives in their routine community activities. We assessed change in male partner participation in ANC and PMTCT using the proportion of women testing for HIV together with their partners (i.e. couple HIV testing) by quarter. We used 203 ANC facilities (attending about 31,000 new pregnant women per quarter) in the same area as control sites. RESULTS: After one year, couple HIV testing in the six intervention sites had tripled from 11.9% at baseline to 36.0% (p<0.001) while there was very little change (from 17.7% to 18.3%) in the 203 control sites (p = 0.07). Statistically significant improvements in couple testing were observed in four of the six intervention sites (6.7% to 19.1%; 9.3% to 74.6%; 46.2% to 95.2%; and 4.7% to 15.1% respectively. p<0.001 for all sites). Two of these four sites, located in the same administrative district as the best practice site, achieved remarkably high couple HIV testing (95.2% and 74.6%). This may be attributable to the greater engagement and active participation of the community leaders in these two sites compared to the other four. CONCLUSION: Effective engagement and functional partnerships between healthcare providers and community leaders can contribute to improve male partner participation in ANC and PMTCT services. PMTCT programs should capitalize on community leaders, in addressing low male partner participation in ANC and PMTCT, in order to improve effective uptake, retention and outcomes of HIV prevention and treatment services among pregnant and breastfeeding women, their partners, infants and families.