Table 1

Summary of STAR Initiative-funded studies of community-based HIVST distribution

Study authorLocationEligible populationStudy designPrimary outcome and evaluationIntervention descriptionIntervention duration and datesART initiation measurement duration and datesMain and exploratory analyses
Indravudh et al 17 Blantyre, Machinga, Mwanza, and Neno districts, MalawiAdult (≥16 years) residents of 22 HCF catchment areasCluster RCT with baseline and endline household surveysHIV testing within past 12 months evaluated with baseline and endline household surveyDoor-to-door distribution of HIVST by resident distributors over at least 12 monthsAt least 12 months per location, September 2016–January 2018ART initiations listing study villages as place of residence were extracted from health facility registers. Data were modelled as initiations per 1000 population. No data collected for the period prior to the interventionMain analysis compared ART initiations in HIVST and non-HIVST clinics during full 12-month intervention period.
Exploratory analysis showed most pronounced effects at months 6–12, corresponding to peak distribution period
Indravudh et al 8 Mangochi district, MalawiAdult (≥15 years) residents of 30 group village head clustersCluster RCT evaluated with endline household surveySelf-reported lifetime HIV testing among adolescents, evaluated with endline surveyEngage established community health groups to lead the HIVST campaigns in their areas, with suggested emphasis on door-to-door7-day campaigns in each location, October 2018–January 2019Staff at health facilities in intervention and comparison areas interviewed new ART initiators during and for 6 months following the intervention. ART initiations were modelled as cumulative incidence per 1000 over the 6 months periodMain analysis compared ART initiations in HIVST and non-HIVST clinics for 6 months following ST distribution campaign.
Exploratory analysis showed most pronounced effects at months 1–3 with minimal effect in months 4–6
Neuman et al 18 Lusaka, Choma, Kapiri Mposhi, and Ndola districts, ZambiaAdult (≥16 years) residents of 16 healthcare facility catchment areasPair-matched cluster RCT evaluated with baseline and endline household surveyHIV testing within past 12 months evaluated with baseline and endline household surveyHIVST distribution by community distributors door-to-door, in high-density public areas, in health facilities, and by trained VMMC promoters in 3 of 6 clustersAt least 12 months per location, September 2016–May 2018Research staff collected data on ART initiations from records kept by health facilities in intervention and comparison districts. Data were collected for at least 5 months before the intervention and at least 11 months during the interventionMain analysis compared ART initiations in HIVST and non-HIVST clinics during full 12-month intervention period.
No exploratory analysis
Sibanda et al 13 Buhera, Bulilima, Chivi, Gutu, Gweru, Mazowe, and Masvingo districts, ZimbabweAdult (≥16 years) residents of 38 wardsQuasi-experimental design*Proportion of individuals who report attending health facility following HIV self-test kit distribution, evaluated with endline household surveyHIVST distribution by community distributors with and without a financial incentive for each client linked to additional services4–6 weeks of distribution per cluster, September 2016–July 2017Catchment areas of all public sector facilities providing ART in each district were mapped in relation towards of both trial arms, categorised into clinics with and without catchment-area HIVST distribution, and paired with one ward receiving HIVST distribution for the purposes of defining before-during-after HIVST time points. ART initiations per month were extracted from clinic registers for the period 6 months before HIVST distribution, during distribution and 3 months following completion of distributionMain analysis compared ART initiations in HIVST and non-HIVST clinics before, during and after distribution campaigns.
No exploratory analysis
Sibanda et al 16 Mutoko, Muzarabani, Shamva, Shurugwi
Umguza, and Zvimba districts, Zimbabwe
Adult (≥16 years) residents of 40 village head man unitsQuasi-experimental design†Self-reported linkage to confirmatory testing, VMMC or PrEP among self-testers, and proportion of individuals reporting a new HIV diagnosis, both measured using endline household surveyHIVST distribution by community distributors or in campaigns led by community membersFour weeks of distribution per cluster, March–October 2019Data on monthly numbers of ART initiations from facilities within and outside HIVST distribution areas were collected from registers at all facilities in the six districts for the periods 6 months before HIVST distribution, during distribution and 3 months postdistributionMain analysis compared ART initiations in HIVST and non-HIVST clinics before, during and after distribution campaigns.
Exploratory analysis compares all facilities before, during and after distribution due to substantial diffusion of intervention into non-HIVST clinics
  • *A cluster-randomised trial assessed the effectiveness of a linkage incentive paid to HIVST distributors versus no incentive and found no impact. While both trial arms received HIVST distribution, a non-randomised comparison area (no community distribution of HIVST kits) was used to assess the association between HIVST distribution and ART initiation.

  • †A cluster-randomised trial assessed the effectiveness of a community-led HIVST intervention compared with distribution by lay health workers and found no impact on ART initiations. While both trial arms received HIVST distribution, a non-randomised comparison area (no community distribution of HIVST kits) was used to assess the association between HIVST distribution and ART initiation.

  • ART, antiretroviral therapy; HIVST, HIV self-testing; PLHIV, people living with HIV; PrEP, pre-exposure prophylaxis; RCT, randomised controlled trial; VMMC, voluntary medical male circumcision.