scholarly journals Community-led delivery of HIV self-testing to improve HIV testing, ART initiation and broader social outcomes in rural Malawi: study protocol for a cluster-randomised trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Pitchaya P. Indravudh ◽  
Katherine Fielding ◽  
Moses K. Kumwenda ◽  
Rebecca Nzawa ◽  
Richard Chilongosi ◽  
...  
Keyword(s):  
Hiv Prevention ◽  
Hiv Testing ◽  
Randomised Trial ◽  
Social Outcomes ◽  
Public Health Issue ◽  
Community Based ◽  
Art Initiation ◽  
Cluster Randomised ◽  
Self Testing ◽  
Catchment Areas

Abstract Background Prevention of new HIV infections is a critical public health issue. The highest HIV testing gaps are in men, adolescents 15–19 years old, and adults 40 years and older. Community-based HIV testing services (HTS) can contribute to increased testing coverage and early HIV diagnosis, with HIV self-testing (HIVST) strategies showing promise. Community-based strategies, however, are resource intensive, costly and not widely implemented. A community-led approach to health interventions involves supporting communities to plan and implement solutions to improve their health. This trial aims to determine if community-led delivery of HIVST can improve HIV testing uptake, ART initiation, and broader social outcomes in rural Malawi. Methods The trial uses a parallel arm, cluster-randomised design with group village heads (GVH) and their defined catchment areas randomised (1:1) to community-led HIVST or continue with the standard of the care (SOC). As part of the intervention, informal community health cadres are supported to plan and implement a seven-day HIVST campaign linked to HIV treatment and prevention. Approximately 12 months after the initial campaign, intervention GVHs are randomised to lead a repeat HIVST campaign. The primary outcome includes the proportion of adolescents 15–19 years old who have tested for HIV in their lifetime. Secondary outcomes include recent testing in adults 40 years and older and men; ART initiation; knowledge of HIV prevention; and HIV testing stigma. Outcomes will be measured through cross-sectional surveys and clinic registers. Economic evaluation will determine the cost per person tested, cost per person diagnosed, and incremental cost effectiveness ratio. Discussion To the best of our knowledge, this is the first trial to assess the effectiveness of community-led HTS, which has only recently been enabled by the introduction of HIVST. Community-led delivery of HIVST is a promising new strategy for providing periodic HIV testing to support HIV prevention in rural communities. Further, introduction of HIVST through a community-led framework seems particularly apt, with control over healthcare concurrently devolved to individuals and communities. Trial registration Clinicaltrials.gov registry (NCT03541382) registered 30 May 2018.

scholarly journals Effect of community-led delivery of HIV self-testing on HIV testing and antiretroviral therapy initiation in Malawi: A cluster-randomised trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (5) ◽  
pp. e1003608
Author(s):  
Pitchaya P. Indravudh ◽  
Katherine Fielding ◽  
Moses K. Kumwenda ◽  
Rebecca Nzawa ◽  
Richard Chilongosi ◽  
...  
Keyword(s):  
Older Adults ◽  
Hiv Testing ◽  
Primary Outcome ◽  
Randomised Trial ◽  
Hiv Treatment ◽  
Cluster Randomised Trial ◽  
Post Intervention ◽  
Art Initiation ◽  
Cluster Randomised ◽  
Self Testing

Background Undiagnosed HIV infection remains substantial in key population subgroups including adolescents, older adults, and men, driving ongoing transmission in sub-Saharan Africa. We evaluated the impact, safety, and costs of community-led delivery of HIV self-testing (HIVST), aiming to increase HIV testing in underserved subgroups and stimulate demand for antiretroviral therapy (ART). Methods and findings This cluster-randomised trial, conducted between October 2018 and July 2019, used restricted randomisation (1:1) to allocate 30 group village head clusters in Mangochi district, Malawi to the community-led HIVST intervention in addition to the standard of care (SOC) or the SOC alone. The intervention involved mobilising community health groups to lead the design and implementation of 7-day HIVST campaigns, with cluster residents (≥15 years) eligible for HIVST. The primary outcome compared lifetime HIV testing among adolescents (15 to 19 years) between arms. Secondary outcomes compared: recent HIV testing (in the last 3 months) among older adults (≥40 years) and men; cumulative 6-month incidence of ART initiation per 100,000 population; knowledge of the preventive benefits of HIV treatment; and HIV testing stigma. Outcomes were measured through a post-intervention survey and at neighboring health facilities. Analysis used intention-to-treat for cluster-level outcomes. Community health groups delivered 24,316 oral fluid-based HIVST kits. The survey included 90.2% (3,960/4,388) of listed participants in the 15 community-led HIVST clusters and 89.2% (3,920/4,394) of listed participants in the 15 SOC clusters. Overall, the proportion of men was 39.0% (3,072/7,880). Most participants obtained primary-level education or below, were married, and reported a sexual partner. Lifetime HIV testing among adolescents was higher in the community-led HIVST arm (84.6%, 770/910) than the SOC arm (67.1%, 582/867; adjusted risk difference [RD] 15.2%, 95% CI 7.5% to 22.9%; p < 0.001), especially among 15 to 17 year olds and boys. Recent testing among older adults was also higher in the community-led HIVST arm (74.5%, 869/1,166) than the SOC arm (31.5%, 350/1,111; adjusted RD 42.1%, 95% CI 34.9% to 49.4%; p < 0.001). Similarly, the proportions of recently tested men were 74.6% (1,177/1,577) and 33.9% (507/1,495) in the community-led HIVST and SOC arms, respectively (adjusted RD 40.2%, 95% CI 32.9% to 47.4%; p < 0.001). Knowledge of HIV treatment benefits and HIV testing stigma showed no differences between arms. Cumulative incidence of ART initiation was respectively 305.3 and 226.1 per 100,000 population in the community-led HIVST and SOC arms (RD 72.3, 95% CI −36.2 to 180.8; p = 0.18). In post hoc analysis, ART initiations in the 3-month post-intervention period were higher in the community-led HIVST arm than the SOC arm (RD 97.7, 95% CI 33.4 to 162.1; p = 0.004). HIVST uptake was 74.7% (2,956/3,960), with few adverse events (0.6%, 18/2,955) and at US$5.70 per HIVST kit distributed. The main limitations include the use of self-reported HIV testing outcomes and lack of baseline measurement for the primary outcome. Conclusions In this study, we found that community-led HIVST was effective, safe, and affordable, with population impact and coverage rapidly realised at low cost. This approach could enable community HIV testing in high HIV prevalence settings and demonstrates potential for economies of scale and scope. Trial registration Clinicaltrials.gov NCT03541382.

scholarly journals Does community-based distribution of HIV self-tests increase uptake of HIV testing? Results of pair-matched cluster randomised trial in Zambia

2021 ◽  
Vol 6 (Suppl 4) ◽  
pp. e004543 ◽  
Author(s):  
Melissa Neuman ◽  
Bernadette Hensen ◽  
Alwyn Mwinga ◽  
Namwinga Chintu ◽  
Katherine L Fielding ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Randomised Trial ◽  
Population Based ◽  
Cluster Randomised Trial ◽  
Distribution Models ◽  
Community Based ◽  
Adjusted Risk ◽  
Cluster Randomised ◽  
Catchment Areas ◽  
The Impact

ObjectivesEnding HIV by 2030 is a global priority. Achieving this requires alternative HIV testing strategies, such as HIV self-testing (HIVST) to reach all individuals with HIV testing services (HTS). We present the results of a trial evaluating the impact of community-based distribution of HIVST in community and facility settings on the uptake of HTS in rural and urban Zambia.DesignPair-matched cluster randomised trial.MethodsIn catchment areas of government health facilities, OraQuick HIVST kits were distributed by community-based distributors (CBDs) over 12 months in 2016–2017. Within matched pairs, clusters were randomised to receive the HIVST intervention or standard of care (SOC). Individuals aged ≥16 years were eligible for HIVST. Within communities, CBDs offered HIVST in high traffic areas, door to door and at healthcare facilities. The primary outcome was self-reported recent testing within the previous 12 months measured using a population-based survey.ResultsIn six intervention clusters (population 148 541), 60 CBDs distributed 65 585 HIVST kits. A recent test was reported by 66% (1622/2465) in the intervention arm compared with 60% (1456/2429) in SOC arm (adjusted risk ratio 1.08, 95% CI 0.94 to 1.24; p=0.15). Uptake of the HIVST intervention was low: 24% of respondents in the intervention arm (585/2493) used an HIVST kit in the previous 12 months. No social harms were identified during implementation.ConclusionDespite distributing a large number of HIVST kits, we found no evidence that this community-based HIVST distribution intervention increased HTS uptake. Other models of HIVST distribution, including secondary distribution and community-designed distribution models, provide alternative strategies to reach target populations.Trial registration numberClinicalTrials.gov Registry (NCT02793804).

Home-based oral self-testing for absent and declining individuals during a door-to-door HIV testing campaign in rural Lesotho (HOSENG): a cluster-randomised trial

2020 ◽  
Vol 7 (11) ◽  
pp. e752-e761 ◽  
Author(s):  
Alain Amstutz ◽  
Thabo Ishmael Lejone ◽  
Lefu Khesa ◽  
Josephine Muhairwe ◽  
Moniek Bresser ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Home Based ◽  
Self Testing

scholarly journals Peer-led HIV care and the UNAIDS 90-90-90 treatment targets in Tigrai, Ethiopia: a cluster randomised trial and economic evaluation of teach-test-link-trace model (TTLT) trial protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e043943
Author(s):  
Hailay Gesesew ◽  
Paul Ward ◽  
Jonathan Karnon ◽  
Richard Woodman ◽  
Lillian Mwanri
Keyword(s):  
Economic Evaluation ◽  
Hiv Testing ◽  
Randomised Trial ◽  
Nominal Group ◽  
Hiv Care ◽  
Cluster Randomised Trial ◽  
Peer Educators ◽  
Hiv Status ◽  
Cluster Randomised ◽  
Self Testing

IntroductionThis study will evaluate the acceptability and effectiveness of a new intervention programme called teach-test-link-trace (TTLT) model in Tigrai, Ethiopia, where peer educators counsel about HIV (teach), perform house-to-house HIV testing (test) through pinprick HIV testing (H2H) or OraQuick HIV self-testing (HIVST), link HIV-positive patients to HIV care (link) and trace lost patients house-to-house (trace).Methods and analysisThe four-arm cluster randomised trial will be conducted in five phases: Phase 1 will assess the acceptability of the TTLT model using a cross-sectional survey among adults aged 18 years irrespective of HIV status in 6909 households from 40 villages (kebeles). Phase 2 will assess effectiveness of the TTLT model through comparing intervention and control groups among HIV negative or unknown HIV status. The intervention groups will receive one of the three home-based interventions provided by peer educators: (1) demonstrate and distribute OraQuick HIV self-testing kits (HIVST), (2) perform pinprick HIV testing (H2H) and (3) offer a choice to either receive HIVST or H2H. The control group will receive the standard care in which nurses counsel and refer eligible household members to nearby health facilities to access existing HIV testing services. The primary outcomes of the interventions are proportion of individuals who know of their HIV status (first 90), link to HIV care and treatment (second 90) and meet virological suppression (third 90). We will perform process evaluation through qualitative interviews in phase 3, economic evaluation for cost-effectiveness analysis in phase 4 and a sustainability exit strategy using nominal group technique in phase 5. We will apply descriptive and inferential statistics for quantitative studies, and thematic framework analysis for qualitative studies.Ethics and disseminationEthics approval was obtained from the Southern Adelaide Clinical Health Research Ethics Committee (SAC HREC), South Australia, and findings will be disseminated through publications, conference presentations, media release and policy briefs.Trial registration numberACTRN12620000570987p.

scholarly journals Effect of door-to-door distribution of HIV self-testing kits on HIV testing and antiretroviral therapy initiation: a cluster randomised trial in Malawi

2021 ◽  
Vol 6 (Suppl 4) ◽  
pp. e004269
Author(s):  
Pitchaya P Indravudh ◽  
Katherine Fielding ◽  
Richard Chilongosi ◽  
Rebecca Nzawa ◽  
Melissa Neuman ◽  
...  
Keyword(s):  
Antiretroviral Therapy ◽  
Hiv Testing ◽  
Randomised Trial ◽  
Health Facilities ◽  
Cluster Randomised Trial ◽  
High Coverage ◽  
Adjusted Risk ◽  
Cluster Randomised ◽  
Self Testing ◽  
Lifetime Testing

IntroductionReaching high coverage of HIV testing remains essential for HIV diagnosis, treatment and prevention. We evaluated the effectiveness and safety of door-to-door distribution of HIV self-testing (HIVST) kits in rural Malawi.MethodsThis cluster randomised trial, conducted between September 2016 and January 2018, used restricted 1:1 randomisation to allocate 22 health facilities and their defined areas to door-to-door HIVST alongside the standard of care (SOC) or the SOC alone. The study population included residents (≥16 years). HIVST kits were provided door-to-door by community-based distribution agents (CBDAs) for at least 12 months. The primary outcome was recent HIV testing (in the last 12 months) measured through an endline survey. Secondary outcomes were lifetime HIV testing and cumulative 16-month antiretroviral therapy (ART) initiations, which were captured at health facilities. Social harms were reported through community reporting systems. Analysis compared cluster-level outcomes by arm.ResultsOverall, 203 CBDAs distributed 273 729 HIVST kits. The endline survey included 2582 participants in 11 HIVST clusters and 2908 participants in 11 SOC clusters. Recent testing was higher in the HIVST arm (68.5%, 1768/2582) than the SOC arm (48.9%, 1422/2908), with adjusted risk difference (RD) of 16.1% (95% CI 6.5% to 25.7%). Lifetime testing was also higher in the HIVST arm (86.9%, 2243/2582) compared with the SOC arm (78.5%, 2283/2908; adjusted RD 6.3%, 95% CI 2.3% to 10.3%). Differences were most pronounced for adolescents aged 16–19 years (adjusted RD 18.6%, 95% CI 7.3% to 29.9%) and men (adjusted RD 10.2%, 95% CI 3.1% to 17.2%). Cumulative incidence of ART initiation was 1187.2 and 909.0 per 100 000 population in the HIVST and SOC arms, respectively (adjusted RD 309.1, 95% CI −95.5 to 713.7). Self-reported HIVST use was 42.5% (1097/2582), with minimal social harms reported.ConclusionDoor-to-door HIVST increased recent and lifetime testing at population level and showed high safety, underscoring potential for HIVST to contribute to HIV elimination goals in priority settings.Trial registration numberNCT02718274.

scholarly journals Community based distribution of oral HIV self-testing kits in Zambia: a cluster-randomised trial nested in four HPTN 071 (PopART) intervention communities

2019 ◽  
Vol 6 (2) ◽  
pp. e81-e92 ◽  
Author(s):  
Chama Mulubwa ◽  
Bernadette Hensen ◽  
Mwelwa M Phiri ◽  
Kwame Shanaube ◽  
Albertus J Schaap ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Community Based ◽  
Cluster Randomised ◽  
Self Testing

scholarly journals Pragmatic economic evaluation of community-led delivery of HIV self-testing in Malawi

2021 ◽  
Vol 6 (Suppl 4) ◽  
pp. e004593
Author(s):  
Pitchaya P Indravudh ◽  
Katherine Fielding ◽  
Linda A Sande ◽  
Hendramoorthy Maheswaran ◽  
Saviour Mphande ◽  
...  
Keyword(s):  
Economic Evaluation ◽  
Incremental Cost ◽  
Hiv Testing ◽  
Unit Cost ◽  
Randomised Trial ◽  
Cost Effective ◽  
Hiv Positive ◽  
Individual Level ◽  
Self Testing ◽  
Catchment Areas

IntroductionCommunity-based strategies can extend coverage of HIV testing and diagnose HIV at earlier stages of infection but can be costly to implement. We evaluated the costs and effects of community-led delivery of HIV self-testing (HIVST) in Mangochi District, Malawi.MethodsThis economic evaluation was based within a pragmatic cluster-randomised trial of 30 group village heads and their catchment areas comparing the community-led HIVST intervention in addition to the standard of care (SOC) versus the SOC alone. The intervention involved mobilising community health groups to lead 7-day HIVST campaigns including distribution of HIVST kits. The SOC included facility-based HIV testing services. Primary costings estimated economic costs of the intervention and SOC from the provider perspective, with costs annualised and measured in 2018 US$. A postintervention survey captured individual-level data on HIV testing events, which were combined with unit costs from primary costings, and outcomes. The incremental cost per person tested HIV-positive and associated uncertainty were estimated.ResultsOverall, the community-led HIVST intervention costed $138 624 or $5.70 per HIVST kit distributed, with test kits and personnel the main contributing costs. The SOC costed $263 400 or $4.57 per person tested. Individual-level provider costs were higher in the community-led HIVST arm than the SOC arm (adjusted mean difference $3.77, 95% CI $2.44 to $5.10; p<0.001), while the intervention effect on HIV positivity varied based on adjustment for previous diagnosis. The incremental cost per person tested HIV positive was $324 but increased to $1312 and $985 when adjusting for previously diagnosed self-testers or self-testers on treatment, respectively. Community-led HIVST demonstrated low probability of being cost-effective against plausible willingness-to-pay values, with HIV positivity a key determinant.ConclusionCommunity-led HIVST can provide HIV testing at a low additional unit cost. However, adding community-led HIVST to the SOC was not likely to be cost-effective, especially in contexts with low prevalence of undiagnosed HIV.Trial registration numberNCT03541382.

Peer assisted HIV self-testing increases positivity rates among key populations in Burundi: descriptive analysis of routine programmatic data (Preprint)

2020 ◽  
Author(s):  
Tiffany Lillie ◽  
Dorica Boyee ◽  
Gloriose Kamariza ◽  
Alphonse Nkunzimana ◽  
Dismas Gashobotse ◽  
...  
Keyword(s):  
Hiv Testing ◽  
Sex Workers ◽  
Descriptive Analysis ◽  
Case Finding ◽  
Hiv Positive ◽  
Key Populations ◽  
Standard Testing ◽  
Art Initiation ◽  
Treatment Standard ◽  
Self Testing

BACKGROUND In Burundi, given the low testing numbers among key populations, peer assisted HIV self-testing (HIVST) was initiated for female sex workers (FSWs), men who have sex with men (MSM), and transgender people (TG) to provide another testing option. HIVST was provided by existing peer outreach workers (POWs) who were trained to provide support before, during, and after the administration of the test. People who screened reactive were referred and actively linked to confirmatory testing, and those confirmed positive were linked to treatment. Standard testing included HIV testing by clinical staff either at mobile clinics or in facilities. OBJECTIVE The objective was to improve access to HIV testing to underserved KP members, increase HIV positivity rates, and link those who were confirmed HIV positive with life-saving treatment for epidemic control. METHODS A descriptive analysis of routine programmatic data was conducted from a nine-month implementation period (June 2018-March 2019) of peer assisted HIVST among FSWs, MSM, and TG in six provinces where the USAID- and PEPFAR-funded LINKAGES Burundi project worked. Chi-squared tests were used to compare case-finding rates among individuals tested through HIVST versus standard testing. RESULTS A total of 2,198 HIVST test kits were administered (1,791 FSWs, 363 MSM, 44 TG). Three hundred and sixty-six people (17%) were reactive to HIV screening (296 FSWs, 60 MSM, 10 TG); 314 (14%) were confirmed HIV positive (257 FSWs, 47 MSM, 10 TG); and 301 (96%) (251 FSWs, 40 MSM, 10 TG) of those confirmed were initiated on treatment. HIV case-finding rates were significantly higher with HIVST compared to standard testing for FSW and MSM but not TG: FSWs (14% vs. 9%, P < .001); MSM (13% vs. 4%, P < .001); and TG (23% vs. 17%, P > .10). ART initiation rates were significantly lower for MSM confirmed HIV positive through HIVST than through standard testing (85% vs. 99%, P < .001) but not among FSWs or TG (FSWs: 98% vs. 97%, P > .10; TG: 100% vs. 100%). CONCLUSIONS The results demonstrate the potential effectiveness of HIVST in identifying individuals who are living with HIV.

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