Similar costs and outcomes for differentiated service delivery models for HIV treatment in Uganda.

This cost-outcome study estimated, from the perspective of the service provider, the total annual cost per client on antiretroviral therapy (ART) and total annual cost per client virally suppressed (defined as < 1000 copies/ml at the time of the study) in Uganda in five ART differentiated service delivery models (DSDMs). These included both facility- and community-based models and the standard of care (SOC), known as the facility-based individual management (FBIM) model. The Ministry of Health (MOH) adopted guidelines for DSDMs in 2017 and sought to measure their costs and outcomes, in order to effectively plan for their resourcing, implementation, and scale-up. In Uganda, the standard of care (FBIM) is considered as a DSDM option for clients requiring specialized treatment and support, or for those who select not to join an alternative DSDM. Note that clients on second-line regimes and considered as "established on treatment" can join a suitable DSDM.Using retrospective client record review of a cohort of clients over a two-year period, with bottom-up collection of clients' resource utilization data, top-down collection of above-delivery level and delivery-level providers' fixed operational costs, and local unit costs. Forty-seven DSDMs located at facilities or community-based points in the four regions of Uganda were included in the study, with 653 adults on ART (> 18 years old) enrolled in a DSDM. The study found that retention in care was 98% for the sample as a whole [96-100%], and viral suppression, 91% [86-93%]. The mean cost to the provider (MOH or NGO implementers) was $152 per annum per client treated, ranging from $141 to $166. Differences among the models' costs were largely due to clients' ARV regimens and the proportions of clients on second line regimens. Service delivery costs, excluding ARVs, other medicines and laboratory tests, were modest, ranging from $9.66-16.43 per client per year. We conclude that differentiated ART service delivery in Uganda achieved excellent treatment outcomes at a cost similar to the standard of care. While large budgetary savings might not be immediately realized, the reallocation of "saved" staff time could improve health system efficiency and with their equivalent or better outcomes and large benefits to clients, client-centred differentiated models would nevertheless add great societal value.

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.

Twelve-Month Outcomes of Community-Based Differentiated Models of Multimonth Dispensing of ART Among Stable HIV-Infected Adults in Lesotho: A Cluster-Randomized Noninferiority Trial.

BACKGROUND: Lesotho adopted the test-and-treat approach for HIV treatment in June 2016, which increased antiretroviral treatment (ART) clinic volume. We evaluated community-based vs. facility-based differentiated models of multimonth dispensing of ART among stable HIV-infected adults in Lesotho. METHODS: Thirty facilities were randomized to 3 arms, facility 3-monthly ART (3MF) (control), community ART groups (3MC), and 6-monthly community distribution points (6MCD). We estimated risk differences (RDs) between arms using population-averaged generalized estimating equations, controlling for baseline imbalances and specifying for clustering. The primary outcome was retention in ART care by intention-to-treat and virologic suppression as a secondary outcome (ClinicalTrials.gov: NCT03438370). RESULTS: A total of 5,336 participants were enrolled, with 1898, 1558, and 1880 in 3MF, 3MC, and 6MCD, respectively. Retention in ART care was not different across arms and achieved the prespecified noninferiority limit (-3.25%) between 3MC vs. 3MF (control); 6MCD vs. 3MF; and 6MCD vs. 3MC, adjusted RD = -0.1% [95% confidence interval (CI): -1.6% to 1.5%], adjusted RD = -1.3% (95% CI: -3.0% to 0.5%), and adjusted RD = -1.2% (95% CI: -2.9% to 0.5%), respectively. After 12 months, 98.6% (n = 1503), 98.1% (n = 1126), and 98.3% (n = 1285) were virally load (VL) suppressed in 3MF, 3MC, and 6MCD, respectively. There were no differences in VL between 3MC vs. control and 6MCD vs. control, risk ratio (RR) = 1.00 (95% CI: 0.98 to 1.01) and RR = 1.00 (95% CI: 0.98 to 1.01), respectively. CONCLUSIONS: There were no differences in retention and VL suppression for stable HIV-infected participants receiving multimonth dispensing of ART within community-based differentiated models when compared with the facility-based standard-of-care model.

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.

Effective public-private partnerships for sustainable antiretroviral therapy: outcomes of the Right to Care health services GP down-referral program.

BACKGROUND: The recently increased access to antiretroviral therapy (ART) in South Africa has placed additional strain on human and infrastructure resources of the public health sector. Capacity from private-sector General Practitioners (GPs) could be leveraged to ease the current burden on the public health sector. METHODS: We conducted a retrospective record review of routine electronic medical record data on a systematic sample of HIV-infected adults (≥18 years old) initiated on ART at a tertiary hospital outpatient HIV clinic in Johannesburg, South Africa and down-referred to private-GPs for continued care after stabilization on ART. We compared these patients ("GP down-referred") to a control-cohort who remained at the referring site ("Clinic A") and patients from a regional hospital outpatient HIV clinic not offering down-referral to GPs ("Clinic B"). Study outcomes assessed are viral load suppression (VL < 50 copies/ml) and attrition from care (all-cause-mortality or > 90-days late for a last-scheduled visit) by 12 months of follow-up following down-referral or eligibility. RESULTS: A total of 3685 patients, comprising 373 (10.1%) GP down-referred, 2599 (70.5%) clinic A controls, and 713 (19.4%) clinic B controls were included in the analysis. Overall, 1535 patients (53.3%) had a suppressed viral load. A higher portion of GP down-referred patients had a suppressed viral load compared to clinic A and B patients (65.7% vs 49.1% vs 58.9%). After adjusting for demographic and baseline clinical covariates, we found no difference in viral load suppression between GP down-referred and control patients (adjusted relative risk [aRR] for clinic A vs GP down-referred 1.0; 95% CI: 0.9-1.1), (aRR for clinic B vs GP down-referred 1.0; 95% CI: 0.9-1.2). Clinic B controls experienced the highest attrition compared to GP down-referred and clinic A controls (33.2% vs 11.3% vs 5.9%) and had a higher risk of attrition compared to GP down-referred patients (adjusted hazard ratio [aHR] 4.2; 95% CI: 2.8-6.5), whereas clinic B controls had a lower risk of attrition (aHR 0.5; 95% CI: 0.3-0.7). CONCLUSIONS AND RECOMMENDATIONS: Our results show that private-GPs can contribute to caring for stabilized public sector HIV patients on life-long ART. However, they require special efforts to improve retention in care.

Varying intervals of antiretroviral medication dispensing to improve outcomes for HIV patients (The INTERVAL Study): study protocol for a randomized controlled trial.

BACKGROUND: Requirements for frequent dispensing of antiretroviral therapy (ART) place demands on health systems and can lead to suboptimal adherence and disengagement in care for patients due to the time and cost of frequent clinic visits. Rigorous data are needed to define optimal ART dispensing strategies and to evaluate the impact of a longer medication supply on retention and virologic suppression and determine whether this strategy lowers costs for both the patient and the health system. To date, no randomized studies have tested the benefits of 6-month dispensing of ART compared to 3-month and standard of care approaches. METHODS: This study will be an unblinded cluster-randomized, matched controlled trial conducted among 8200 stable, HIV-infected individuals age 18 years and older on ART in Malawi and Zambia, to compare three ART dispensing intervals on the outcomes of retention in care (primary outcome), virologic suppression, and cost-effectiveness. Thirty clusters will be matched according to country, facility type, and ART cohort size and randomized to one of three study arms: standard of care, 3-month dispensing, and 6-month dispensing. Study participants will be followed, and outcomes will be measured at 12, 24, and 36 months. A subset of participants (n = 240) and providers (n = 180) will also participate in qualitative interviews to evaluate feasibility and acceptability of different ART dispensing intervals. DISCUSSION: This study will be the first to compare 6-month and 3-month ART dispensing intervals for stable, HIV-infected individuals in Malawi and Zambia. We focus on outcomes relevant to country programs, including retention, virologic suppression, and cost-effectiveness. Results from the study will help resource-limited health systems better understand the full scope of outcomes resulting from various ART dispensing intervals and help to inform health policy decisions. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03101592 . Registered on 18 March 2017. Pan African Clinical Trials, PACTR201706002336105 . Registered on 2 June 2017.

Same-Day CD4 Testing to Improve Uptake of HIV Care and Treatment in South Africa: Point-of-Care Is Not Enough.

Background. We evaluated whether a pilot program providing point-of-care (POC), but not rapid, CD4 testing (BD FACSCount) immediately after testing HIV-positive improved retention in care. Methods. We conducted a retrospective record review at the Themba Lethu Clinic in Johannesburg, South Africa. We compared all walk-in patients testing HIV-positive during February, July 2010 (pilot POC period) to patients testing positive during January 2008-February 2009 (baseline period). The outcome for those with a ≤250 cells/mm(3) when testing HIV-positive was initiating ART <16 weeks after HIV testing. Results. 771 patients had CD4 results from the day of HIV testing (421 pilots, 350 baselines). ART initiation within 16 weeks was 49% in the pilot period and 46% in the baseline period. While all 421 patients during the pilot period should have been offered the POC test, patient records indicate that only 73% of them were actually offered it, and among these patients only 63% accepted the offer. Conclusions. Offering CD4 testing using a point-of-care, but not rapid, technology and without other health system changes had minor impacts on the uptake of HIV care and treatment. Point-of-care technologies alone may not be enough to improve linkage to care and treatment after HIV testing.