Out-of-facility individual models vary according to where in the community the services are provided, as well as what services are delivered and by whom. They can be divided into three categories: fixed community points including private pharmacies, mobile outreach ART delivery, and home delivery.
Fixed community points
Promising results have been found in models using fixed community points. Evidence has come from the community drug distribution point (CDDP) model in Uganda, the community ART distribution points (PODI) in the Democratic Republic of the Congo (DRC), external pick-up points in South Africa, community pick-up points in Zambia and community private pharmacy collection in Nigeria and Uganda.
In Uganda, cross-sectional outcomes for clients initiating ART from 2004 to 2009 (median time on ART: 5.7 years; interquartile range, IQR: 4.1-7.2 years) in the CDDP model were that 69% were retained in care, 17% had died, 6% were transferred out and 9% were lost to follow up (LTFU). Among CDDP clients, viral load suppression (<1,000 copies/mL) was 93% (median time on ART: 7.0 years; IQR; 5.0-8.0) (1). In a subsequent conference abstract, LTFU was reported as 16.5% in the facility arm and 4.28% in the CDDP arm (p<0.0001) (2). A costing comparison study in Uganda put the model from The AIDS Support Organization (TASO), including TASO-run clinics for new initiations and the CDDP model for stable clients, at US$74/visit and $332/client/year compared with a mobile ART delivery model utilizing expert clients to dispense ART (US$45/visit; $404/client/year) and a facility-based nurse-led model (US$38/visit; $257/client/year) (3).
In the DRC, a retrospective cohort analysis found LTFU and death among PODI clients to be at 2.2% and 0.1% at six months,4.8% and 0.2% at 12 months and 9% and 0.3% at 24 months, respectively, with overall crude attrition of 5.66/100 person years with little variation over time (4). Two 2018 conference abstracts also reported on PODI outcomes. The first on 576 clients enrolled in a PODI from October 2016 to December 2017 reported 12-month retention of 98% (5). The second on 1484 ART clients enrolled at the four PODI houses which resulted in decanting of linked facilities by 44%- 47%. The four PODI houses show high retention rates of 92-100% at 3, 6 and 9 months and VL suppression above 90% (6).
In South Africa, external pick-up points were endorsed as one of its three differentiated ART delivery models. This model allows clients to choose a non-facility based venue for ART refill collection. These include fixed community points, private pharmacies and more recently lockers. National retention and viral load suppression outcomes were evaluated in a 2019 study comparing 24 intervention and control facilities. External pick-up point patients had lower 12-month retention (81.5% versus 87.2%, aRD: −5.9%; CI: −12.5% to 0.8%) and comparable sustained viral suppression (<400 copies/mL any time ≤ 18 months) (77.2% versus 74.3%, aRD: −1.0%; CI: −12.2% to 10.1%). Interestingly, the study reported increased viral suppression among men (RD: 11.1%; 95% CI: −3.4% to 25.5%) (7). A qualitative study of external pick-up points reported quicker and more convenient ART collection in the community, seen as a reward for taking ART well and reduced disruption in client life activities. At private pharmacies, some clients reported receiving inferior care compared with paying customers, and some worried about inadvertently revealing their HIV status. Clients and healthcare workers had to negotiate problems with CCMDD implementation, such as delayed SMS reminders, ART not being available at the external pickup point and a few private pharmacies placing restrictions on ART pickup times (8).
In Zambia, clinically stable clients were able to select community pick-up points for ART refill collection. ART refills were pre-packed by a central dispensing unit. Six participating clinics enrolled 6303 clients to collect from 19 community pick-up points (rural markets, shopping malls and some at clinics) with a 96% retention rate, 94% ART refill pick-up compliance rate and 93% viral suppression rate (<50 copies/ml) (9).
Nigeria is expanding an out-of-facility model where community private pharmacies are linked with public health facilities and clients can elect to collect two-month ART refills from these pharmacies. An early evaluation reported a 100% prescription refill rate and 99.7% retention in care (10). Uganda has also started utilizing private pharmacies with six serving as community ART refill points for stable clients from four high volume health facilities (>8,000 ART clients) (11). A nurse-dispenser distributes ART refills with six-monthly clinical reviews at the health facility. Over a 30-month period (January 2017 to June 19), 9921 (29% men) clients enrolled, representing 30% of clients at the four facilities. Of these, 96% had received ART refills as scheduled, and the average waiting time at the pharmacy was <10 minutes. The 12-month retention rate was 98%, and >99% of enrolled clients remaining virally suppressed.
In Namibia, two high HIV burden districts in northern Namibia with far distances to clinics, implemented C-BART sites (12). Community members constructed basic structures close to their homes where healthcare workers visited quarterly to provide HIV clinical assessment, ART refills and VLs. Clients did not need to attend health facilities. In a retrospective cohort analysis of 909 adults (≥15 years) and 122 children enrolled from 2007-2017, 12,24, 36, 48 and 60-month retention remained >97% for adults and 81.5% for children.
Mobile outreach ART delivery
There is limited published evidence of utilizing mobile outreach services to distribute ART refills outside of the health facility.. In Eswatini, health facilities were offered a choice of three ART delivery models for implementation (Mobile outreach, community ART groups (CAGs) and facility adherence clubs (ACs)). One health centre and one clinic implemented mobile outreach to support remote communities. Among those enrolled in DSD models, 12-month retention was high at 93.7% but retention within model varied substantially (mobile outreach 86.3%; CAG: 70.4%; facility AC 90.4%) (13). In South Africa, comprehensive ART services (including ART refills) were provided by mobile outreach on South African-Zimbabwean border farms to vulnerable, highly mobile Zimbabwean migrant farm workers and their families (14). The intervention piloted a travel package, including a 3-month ART refill. Viral suppression was 91.2%, and of those clients who indicated planned travel to Zimbabwe, only 2% did not return within three months of their planned return date. In a retrospective outcomes analysis of clients who enrolled in DSD models in Zambia from 2015-2017, 12-month retention was 81% in clinic-based care compared with 69% in two-monthly mobile outreach to rural health centres with both cohorts including non-stable clients. Provider costs per person retained was unsurprisingly much higher in the mobile outreach model (USD291 versus USD124) (15).
There are four cluster randomized controlled trials from Kenya and Uganda reporting outcomes from home ART delivery models. In Uganda, there was no difference between the virological failure rates for home versus for facility care (rate ratio, RR, 1.04, 0.78-1.40; equivalence shown) (16). Mortality rates were also similar between the groups (0.95, 0.71-1.28). Health services and patient cost year were less for home delivery compared with facility refill (US$793 vs. $838 for health services and $18 vs. $54 for patient). In Kenya, no significant intervention-control differences were found with regard to detectable viral load, mean CD4 count, change in ART regimen, new opportunistic infections or pregnancy rates. Intervention clients made half as many clinic visits as did controls (17). In Tanzania, a non-inferiority cluster trial randomized 24 health facilities to i) clinic-based ART delivery for all patients or ii) the offer of home-based delivery (HBD) by lay healthcare workers for stable adult clients with an annual clinical review visit at the facility (18). In the intervention arm, 516 (44.4%) of the clients took up offer to receive ART refills in or close to their homes (87.4% of stable clients). At the end of the study period (mean follow-up time was 326 days), loss to follow-up was 18.9% in the intervention clinics and 13.6% in the control clinics with 9.7% (91/943) intervention arm and 10.9% (95/872) control arm clients failing virologically. In Lusaka, Zambia, within the PopART study, clients in two study arms were offered a choice for collecting a three-month ART refill i) clinic-based care or home delivery ii) clinic-based care or community-based AC (19). 12-month viral suppression was non-inferior in the community DSD models (above 98% in all 3 arms). More clients were lost to care in the clinic-base care arm (52/781; HBD 18/825; AC 20/808) with more deaths in the HBD arm (17; clinic-based 2; AC 7).
Two South African studies report on home ART refill delivery. A retrospective cohort study of clients utilizing private healthcare through a private health management scheme compared outcomes between clients receiving their ART refills through a courier service at home (n=14,620) and those who collected their ART refills at a private pharmacy (n=19,202) (20). The likelihood of viral suppression was higher for the home refill group (81% vs 71%, p<0.001. In a marginal structure model (MSM) addressing time-varying aspects and causality, home refill was associated with an even higher benefit (adjusted hazard ratio = 0.66 [95% CI: 0.55-0.78]). A descriptive study reports on eligibility and uptake of home delivery of ART and other chronic disease refills (including hypertension, diabetes, mental health conditions, dyslipidaemia, osteoarthritis, asthma and epilepsy) during the COVID-19 pandemic at a single clinic in the Tshwane health district (21). 32% of 1727 clients evaluated were eligible for home delivery of which 432 (79%) accepted.
- Okoboi S, Ding E, Persuad S, Wangisi J, Birungi J, Shurgold S et al. Community-based ART distribution system can effectively facilitate long-term program retention and low-rates of death and virologic failure in rural Uganda. AIDS research and therapy. 2015 Nov 12;12(1):1.
- Mpima D, Birungi J, Makabayi R, Kanters S, Luzze C. Community Antiretroviral Therapy (ART) delivery models for high patient retention and sustaining good adherence: The AIDS Support Organisation (TASO) operational reseach findings, CDC/PEPFAR funded project in Uganda. Presented at IAS 2013; 2013 30 June-3 July; Kuala Lumpur, Malaysia.
- Vu L, Waliggo S, Zieman B, Jani N, Buzaalirwa L, Okoboi S, et al. Annual cost of antiretroviral therapy among three service delivery models in Uganda. Journal of the International AIDS Society. 2016;19(5 Suppl 4):20840
- Vogt F, Kalenga L, Lukela J, Salumu F, Diallo I, Nico E, et al. Brief Report: Decentralizing ART supply for stable HIV patients to community-based distribution centres: Programme outcomes from an urban context in Kinshasa, DRC. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2017 Mar 1;74(3): 326-331.
- Kamerhe D, Kibwa Milenge P, Monga F, Thior I, Mwamba R et al. Improved HIV treatment retention among patients enrolled in a differentiated care model at Kenya General Reference Hospital in Haut Katanga province of the Democratic Republic of the Congo. Presented at IAS 2019; 2019 July 21-24; Mexico City, Mexico.
- Mothibi E, Mangoma J, Kabamba D, Monteith L, N’siesi FX, Firth J et al. Improving retention, viral suppression, and facility decongestion through community-based individual drug distribution (PODIs) in DRC. 2018. Presented at AIDS 2018; 2018 July 23-17; Amsterdam, the Netherlands.
- Fox MP, Pascoe S, Huber AN, Murphy J, Phokojoe M, Gorgens M, et al. Adherence clubs and decentralized medication delivery to support patient retention and sustained viral suppression in care: Results from a cluster-randomized evaluation of differentiated ART delivery models in South Africa. PLoS medicine. 2019 Jul;16(7).
- Dorward J, Msimango L, Gibbs A, Shozi H, Tonkin-Crine S, Hayward G et al. Understanding how community antiretroviral delivery influences engagement in HIV care: a qualitative assessment of the Centralised Chronic Medication Dispensing and Distribution programme in South Africa. BMJ Open. 2020 May 15;10(5):e035412.
- Hendriksz F, Dube T, Strydom B, Banoo S. Centralized dispensing and alternative pick up points increases access to ARVs in Zambia. Poster presented at IAS 2019; 2019 July 21-24; Mexico City, Mexico
- Avong YK, Kayode GA, Jatau B, Avong EB, Adekanmbi V, Abimiku A, et al. Providing antiretroviral therapy outside the hospital in a low-resource setting: a pilot study. The Lancet Global Health. 2018 Mar 1;6:S3.
- Ssuna M, Nakade S, Kabanda J, Zalwango S, Okello D, Christopher M et al. Community private pharmacy ART Refill in Kampala, Uganda. Poster presented at: CROI 2020: 2020 March 8-11; Boston USA
- Shoopala , NN, Baughman AL, Mengistu A, Mitruka, K, Woelk, G, Mutandi G et al. Outcomes of community-based antiretroviral treatment program in Namibia. Poster presented at CROI 2020: 2020 March 8-11; Boston USA
- Pasipamire L, Nesbitt RC, Ndlovu S, Sibanda G, Mamba S, Lukhele N et al. Retention on ART predictors of disengagement from care in several alternative community-centred ART refills models in rural Swaziland. J Int AIDS Soc. 2018 Sep;21(9): e25183.
- Matambo T, Hildebrand K, Wilkinson L, Van Cutsem G, Bauernfeind A, et al. Targeted adherence strategies for provision of cross border antiretroviral therapy (ART) to migrant farm workers in Musina, South Africa. Poster presented at AIDS 2012; 2012 July 22-27; Washington, USA.
- Nicols BE, Cele R, Jamieson L, Long L, Siwale Z, Banda P et al. Community-based service delivery of HIV treatment in Zambia: costs and outcomes. Poster presented at CROI 2020: 2020 March 8-11; Boston USA
- Jaffar S, Amuron B, Foster S, Birungi J, Levin J, Namara G, et al. Rates of virological failure in patients treated in a home-based versus a facility-based HIV-care model in Jinja, southeast Uganda: a cluster-randomised equivalence trial. The Lancet. 2010;374(9707):2080.
- Selke HM, Kimaiyo S, Sidle JE, Vedanthan R, Tierney WM, Shen C, et al. Task-shifting of antiretroviral delivery from health care workers to persons living with HIV/AIDS: clinical outcomes of a community-based program in Kenya. Journal of Acquired Immune Deficiency Syndromes. 2010;55(4):483-90.
- Geldsetzer P, Francis JM, Sando D, Asmus F, Lema IA, Mboggo E et al. Community delivery of antiretroviral drugs: A non-inferiority cluster-randomized pragmatic trial in Dar es Salaam, Tanzania. PLoS Med. 2018 Sep 19;15(9):e1002659.
- Limbada, M, Macleod D, Chileshe K, Muhau E, Shibwela O, Floyd S et al. Viral suppression in stable HIV+ patients in two community models of ART delivery: A cluster randomized trial nested within HPTN071 (PopART) trial Lusaka, Zambia. Poster presented at AIDS2020: Virtual; 2020 July 6-10;
- Leisegang R, Calkins K, Cotton M, Cleary S, Karamchand S, Hammann F et al. HIV+ patients receiving ARVs through home delivery: Does it matter? A Causal analysis. Poster presented at CROI 2020: 2020 March 8-11; Boston USA
- Louw JM, Rantloane B, Ngcobo S, Brey Z, Hugo J, Basu D et al. Home delivery of medication as part of reducing congestion in primary healthcare in Tshwane District Health Services. S Afr J Public Health. 2020 Aug;4(2):50-55.