Dataset Information

Effect of Prices, Distribution Strategies, and Marketing on Demand for HIV Self-testing in Zimbabwe: A Randomized Clinical Trial.

ABSTRACT:

Importance

HIV self-testing is a promising approach for increasing awareness of HIV status in sub-Saharan Africa, particularly in Zimbabwe, where HIV prevalence is 13%. Evidence is lacking, however, on the optimal pricing policies and delivery strategies for maximizing the effect of HIV self-testing.

Objective

To assess demand for HIV self-testing among adults and priority-population subgroups under alternative pricing and distribution strategies.

Design, setting, and participants

This randomized clinical trial recruited study participants between February 15, 2018, and April 25, 2018, in urban and rural communities in Zimbabwe. A factorial design was used to randomize participants to a combination of self-test price, distribution site, and promotional message. Individuals and their household members had to be at least 16 years old to be eligible for participation. This intention-to-treat population comprised 3996 participants.

Interventions

Participants were given a voucher that could be redeemed for an HIV self-test within 1 month at varying prices (US $0-$3) and distribution sites (clinics or pharmacies in urban areas, and retail stores or community health workers in rural areas). Vouchers included randomly assigned promotional messages that emphasized the benefits of HIV testing.

Main outcomes and measures

Proportion of participants who obtained self-tests in each trial arm, measured by distributor records.

Results

Among the 4000 individuals enrolled, 3996 participants were included. In total, the mean (SD) age was 35 (14.7) years, and most participants (2841 [71.1%]) were female. Self-testing demand was highly price sensitive; 260 participants (32.5%) who were offered free self-tests redeemed their vouchers, compared with 55 participants (6.9%) who were offered self-tests for US $0.50 (odds ratio [OR], 0.14; 95% CI, 0.10-0.19), a reduction in demand of more than 25 percentage points. Demand was below 3% in the $1, $2, and $3 groups, which was statistically significantly lower than the demand in the free distribution group: in pooled analyses, demand was considerably lower among participants in higher-than-$0 price groups compared with the free distribution group (2.8% vs 32.5%; OR, 0.05; 95% CI, 0.04-0.07). In urban areas, demand was statistically significantly higher with pharmacy-based distribution compared with clinic-based distribution (6.8% vs 2.9%; adjusted OR, 2.78; 95% CI, 1.74-4.45). Price sensitivity was statistically significantly higher among rural residents, men, and those who had never received testing before. Promotional messages did not influence demand.

Conclusions and relevance

This study found that demand for HIV self-testing in Zimbabwe was highly price sensitive, suggesting that free distribution may be essential for promoting testing among high-priority population groups; additionally, pharmacy-based distribution was preferable to clinic-based distribution in urban areas.

Trial registration

ClinicalTrials.gov identifier: NCT03559959.

SUBMITTER: Chang W

PROVIDER: S-EPMC6716290 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundSeveral trials of community-based HIV self-testing (HIVST) provide evidence on the acceptability and feasibility of campaign-style distribution to reach first-time testers, men and adolescents. However, we do not know how many remain unaware of HIVST after distribution campaigns, and who these individuals are. Here we look at factors associated with never having heard of HIVST after community-based campaign-style HIVST distribution in rural Zimbabwe between September 2016 and July 2017.MethodsAnalysis of representative population-based trial survey data collected from 7146 individuals following community-based HIVST distribution to households was conducted. Factors associated with having never heard of HIVST were determined using multivariable mixed-effects logistic regression adjusted for clustered design.ResultsAmong survey participants, 1308 (18.3%) self-reported having never heard of HIVST. Individuals who were between 20 and 60 years old {20-29 years: [aOR = 0.74, 95% CI (0.58-0.95)], 30-39 years: [aOR = 0.56, 95% CI (0.42-0.74)], 40-49 years: [aOR = 0.50, 95% CI (0.36-0.68)], 50-59 years [aOR = 0.58, 95% CI (0.42-0.82)]}, who had attained at least ordinary level education [aOR = 0.51, 95% CI (0.34-0.76)], and who had an HIV test before [aOR = 0.30, 95% CI (0.25-0.37)] were less likely to have never heard of HIVST compared with individuals who were between 16 and 19 years old, who had a lower educational level and who had never tested for HIV before, respectively. In addition, non-household heads or household head representatives [aOR = 1.21, 95% CI (1.01-1.45)] were more likely to report never having heard of HIVST compared to household head and representatives.ConclusionsAround one fifth of survey participants remain unaware of HIVST even after an intensive community-based door-to-door HIVST distribution. Of note, those least likely to have heard of self-testing were younger, less educated and less likely to have tested previously. Household heads appear to play an important role in granting or denying access to self-testing to other household members during door-to-door distribution. Differentiated distribution models are needed to ensure access to all. Trial registration PACTR, PACTR201607001701788. Registered 29 June 2016, https://pactr.samrc.ac.za/ PACTR201607001701788.

Project description:BackgroundTargeted HIV testing strategies are needed to reach remaining undiagnosed people living with HIV and achieve the UNAIDS' 95-95-95 goals for 2030. HIV self-testing (HIVST) can increase uptake of HIV testing among young people, but user perspectives on novel distribution methods are uncertain. We assess the acceptability, perceived challenges, and recommendations of young adult lay counselor-led campus-based HIVST delivery among tertiary school students aged 18-24 years in Zimbabwe.MethodsWe purposively sampled participants from an intervention involving campus-based HIVST using lay workers for distribution. We conducted in-depth interviews (IDIs) and focus group discussions (FGDs) among young adults from 10 universities and colleges in Zimbabwe who: (1) self-tested on campus; (2) self-tested off campus; and (3) opted not to self-test. We audio recorded and transcribed all interviews. Using applied thematic analysis, two investigators identified emergent themes and independently coded transcripts, achieving high inter-coder agreement.ResultsOf the 52 young adults (53.8% male, 46.1% female) interviewed through 26 IDIs and four FGDs, most IDI participants (19/26, 73%) favored campus-based HIVST, describing it as a more autonomous, convenient, and socially acceptable experience than other facility or community-based HIV testing services. Despite general acceptability, participants identified challenges with this delivery model, including: perceived social coercion, insufficient privacy and access to post-test counseling. These challenges influenced some participants to opt against self-testing (6/52, 11.5%). Recommendations for improved implementation included integrating secondary distribution of test kits and increased HIV counseling options into campus-based programs.ConclusionsBarriers to HIV testing among young people are numerous and complex. As the number of new HIV infections among youth continue to grow worldwide, targeted strategies and youth friendly approaches that increase access to testing are needed to close the diagnostic coverage gap. This is the first study to describe young adult acceptance of campus-based delivery of HIVST by lay counselors in Zimbabwe.

Project description:BackgroundAchieving higher rates of partner HIV testing and couples testing among pregnant and postpartum women in sub-Saharan Africa is essential for the success of combination HIV prevention, including the prevention of mother-to-child transmission. We aimed to determine whether providing multiple HIV self-tests to pregnant and postpartum women for secondary distribution is more effective at promoting partner testing and couples testing than conventional strategies based on invitations to clinic-based testing.Methods and findingsWe conducted a randomized trial in Kisumu, Kenya, between June 11, 2015, and January 15, 2016. Six hundred antenatal and postpartum women aged 18-39 y were randomized to an HIV self-testing (HIVST) group or a comparison group. Participants in the HIVST group were given two oral-fluid-based HIV test kits, instructed on how to use them, and encouraged to distribute a test kit to their male partner or use both kits for testing as a couple. Participants in the comparison group were given an invitation card for clinic-based HIV testing and encouraged to distribute the card to their male partner, a routine practice in many health clinics. The primary outcome was partner testing within 3 mo of enrollment. Among 570 participants analyzed, partner HIV testing was more likely in the HIVST group (90.8%, 258/284) than the comparison group (51.7%, 148/286; difference = 39.1%, 95% CI 32.4% to 45.8%, p < 0.001). Couples testing was also more likely in the HIVST group than the comparison group (75.4% versus 33.2%, difference = 42.1%, 95% CI 34.7% to 49.6%, p < 0.001). No participants reported intimate partner violence due to HIV testing. This study was limited by self-reported outcomes, a common limitation in many studies involving HIVST due to the private manner in which self-tests are meant to be used.ConclusionsProvision of multiple HIV self-tests to women seeking antenatal and postpartum care was successful in promoting partner testing and couples testing. This approach warrants further consideration as countries develop HIVST policies and seek new ways to increase awareness of HIV status among men and promote couples testing.Trial registrationClinicalTrials.gov NCT02386215.

Project description:BackgroundHIV testing rates in many hyper-endemic areas are lower than needed to curtail the HIV epidemic. New HIV testing strategies are needed to overcome barriers to traditional clinic based testing; HIV self-testing is one modality that offers promise in reaching individuals who experience barriers to clinic-based testing.MethodsWe conducted a randomized control trial among young women ages 18-26 living in rural Mpumalanga, South Africa where they were randomized in a 1:1 allocation to either the: (1) HIV Counseling and Testing (HCT) arm: an invitation to test at one of the 9 local government clinics where free HCT is provided and is standard of care (SOC), or (2) choice arm: choice of either a clinic-based HCT invitation or oral HIV Self-Testing (HIVST) kits. Depending on the arm, participants were also provided either: (1) 4 HCT invitations to provide to peers/partners for HIV testing at one of the 9 local clinics, or (2) 4 HIV self-test kits to provide to peers/partners (thus 5 total HIVST kits or HCT invitations). Young women were asked to return 3 months and 9 months after enrollment to assess testing uptake and invitation or kit distribution to peers and partners and experiences with testing. Peers and partners who were reported by index participants to have received kits/invitations during follow-up visits were also invited to attend a study visit to assess their testing experiences. The trial is registered at clinical trials.gov NCT03162965.Findings287 young women were enrolled and randomized, with 146 randomized to the HCT arm and 141 to the choice (HCT or HIVST) arm. Of those randomized to the choice arm, over 95% (n=135) chose the HIV self-testing kit and only 6 individuals chose HCT. At the 3-month follow-up visit, 92% of index participants in the choice arm reported having tested for HIV compared to 43% of participants in the HCT arm, resulting in a significant risk difference of 49% (95% CI 40%, 58%). By 9 months, this difference decreased to a risk difference of 25% (95% CI 17%, 33%) between arms (96% in the choice arm and 72% in the HCT arm). Participants in the choice arm were also more likely to invite peers and partners to test compared to the HCT arm (94% vs. 76% or an average of 4.97 vs 2.79 tests). Few male partners were invited to test by index participants; however, index participants in the choice arm were more likely to have their male partners test than index participants in the HCT arm (RR 2.99, 95% CI 1.45, 6.16).InterpretationWhen given a choice between clinic-based HIV testing and HIV oral self-testing, the overwhelming majority of young women chose HIVST. In addition, those offered a choice of HIV testing modality were much more likely to test, distribute test kits to peers and partners, and to have peers and partners who reported testing compared to the HCT arm. Self-testing offers an important opportunity to significantly increase testing rates among young women and their peers and partners compared to clinic-based HCT. Other strategies to reach men with testing are needed.FundingUS National Institutes of Health.

Project description:IntroductionHIV self-testing (HIVST) is being introduced as a new way for more undiagnosed people to know their HIV status. As countries start to implement HIVST, assuring the quality and regulating in vitro diagnostics, including HIVST, are essential. We aimed to document the emerging regulatory landscape and perceptions of key stakeholders involved in HIVST policy and regulation prior to implementation in three low- and middle-income countries.MethodsBetween April and August 2016, we conducted semi-structured interviews in Malawi, Zambia and Zimbabwe to understand the relationships between different stakeholders on their perceptions of current and future HIVST regulation and the potential impact on implementation. We purposively sampled and interviewed 66 national-level key stakeholders from the Ministry of Health and the regulatory, laboratory, logistical, donor and non-governmental sectors. We used a thematic approach to analysis with an inductively developed common coding framework to allow inter-country comparison of emerging themes.ResultsIn all countries, the national reference laboratory was monitoring the quality of HIVST kits entering the public sector. In Malawi, there was no legal mandate to regulate medical devices, in Zambia one regulatory body with a clear mandate had started developing regulations and in Zimbabwe the mandate to regulate was overlapping between two bodies. Stakeholders indicated that they had a poor understanding of the process and requirements for HIVST regulation, as well as lack of clarity and coordination between organizational roles. The need for good collaboration between sectors, a strong post-market surveillance model for HIVST and technical assistance to develop regulators capacity was noted as priorities. Key informants identified technical working groups as a potential way collaboration could be improved upon to accelerate the regulation of HIVST.ConclusionRegulation of in vitro diagnostic devices, including HIVST, is now being recognized as important by regulators after a regional focus on pharmaceuticals. HIVST is providing an opportunity for each country to develop similar regulations to others in the region leading to a more coherent regulatory environment for the introduction of new devices.

Project description:As countries approach their scale-up targets for the voluntary medical male circumcision program for HIV prevention, they are strategizing and planning for the sustainability phase to follow. Global guidance recommends circumcising adolescent (below 14 years) and/or early infant boys (aged 0-60 days), and countries need to consider several factors before prioritizing a cohort for their sustainability phase. We provide community and healthcare provider-side insights on attitudes and decision-making process as a key input for this strategic decision in Zambia and Zimbabwe. We studied expectant parents, parents of infant boys (aged 0-60 days), family members and neo-natal and ante-natal healthcare providers in Zambia and Zimbabwe. Our integrated methodology consisted of in-depth qualitative and quantitative one-on-one interviews, and a simulated-decision-making game, to uncover attitudes towards, and the decision-making process for, early adolescent or early infant medical circumcision (EAMC or EIMC). In both countries, parents viewed early infancy and early adolescence as equally ideal ages for circumcision (38% EIMC vs. 37% EAMC in Zambia; 24% vs. 27% in Zimbabwe). If offered for free, about half of Zambian parents and almost 2 in 5 Zimbabwean parents indicated they would likely circumcise their infant boy; however, half of parents in each country perceived that the community would not accept EIMC. Nurses believed their facilities currently could not absorb EIMC services and that they would have limited ability to influence fathers, who were seen as having the primary decision-making authority. Our analysis suggests that EAMC is more accepted by the community than EIMC and is the path of least resistance for the sustainability phase of VMMC. However, parents or community members do not reject EIMC. Should countries choose to prioritize this cohort for their sustainability phase, a number of barriers around information, decision-making by parents, and supply side will need to be addressed.

Project description:BackgroundThe uptake of HIV testing services among adolescents and young adults in Zimbabwe is low due to stigma associated with the risk of mental and social harm. The WHO recommends HIV self-testing (HIVST) as an innovative approach to improve access to HIV testing for this hard-to-reach populations. This study describes the development and implementation of a coordinated multifaceted and multidisciplinary campus-based approach to improve the uptake of HIV testing among university students in Zimbabwe.MethodsWe utilized both quantitative and qualitative methods guided by the Exploration, Preparation, Implementation, and Sustainment Framework. A formative survey, in-depth interviews, and a scoping review were conducted as part of the situation analysis. Implementers (peer educators and health workers) were trained and community dialogue sessions were conducted to ascertain the determinants (enablers and barriers) influencing both the inner and outer contexts. Self-test kits were disbursed over 6 months before a summative evaluation survey was conducted. Qualitative data were analyzed thematically while the chi-squared test was used to analyze quantitative data.ResultsThe formative evaluation showed that 66% of students intended to test and 44% of the enrolled students collected HIVST test kits. Giving comprehensive and tailored information about the intervention was imperative to dispel the initial skepticism among students. Youth-friendly and language-specific packaging of program materials accommodated the students. Despite the high acceptability of the HIVST intervention, post-test services were poorly utilized due to the small and isolated nature of the university community. Implementers recommended that the students seek post-test services off-site to ensure that those with reactive results are linked to treatment and care.ConclusionsPeer-delivered HIVST using trained personnel was acceptable among adolescents and young adults offered the intervention at a campus setting. HIVST could increase the uptake of HIV testing for this population given the stigma associated with facility-based HTS and the need for routine HIV testing for this age group who may not otherwise test. An off-site post-test counseling option is likely to improve the implementation of a campus-based HIVST and close the linkage to treatment and care gap.

Project description:IntroductionHIV self-testing (HIVST) is recommended by the World Health Organization in addition to other testing modalities to increase uptake of HIV testing, particularly among harder-to-reach populations. This study provides the first empirical evidence of the costs of door-to-door community-based HIVST distribution in Malawi, Zambia and Zimbabwe.MethodsHIVST kits were distributed door-to-door in 71 sites across Malawi, Zambia and Zimbabwe from June 2016 to May 2017. Programme expenditures, supplemented by on-site observation and monitoring and evaluation data were used to estimate total economic and unit costs of HIVST distribution, by input and site. Inputs were categorized into start-up, capital and recurrent costs. Sensitivity and scenario analyses were performed to assess the impact of key parameters on unit costs.ResultsIn total, 152,671, 103,589 and 93,459 HIVST kits were distributed in Malawi, Zambia and Zimbabwe over 12, 11 and 10 months respectively. Across these countries, 43% to 51% of HIVST kits were distributed to men. The average cost per HIVST kit distributed was US$8.15, US$16.42 and US$13.84 in Malawi, Zambia and Zimbabwe, respectively, with pronounced intersite variation within countries driven largely by site-level fixed costs. Site-level recurrent costs were 70% to 92% of full costs and 20% to 62% higher than routine HIV testing services (HTS) costs. Personnel costs contributed from 26% to 52% of total costs across countries reflecting differences in remuneration approaches and country GDP.ConclusionsThese early door-to-door community HIVST distribution programmes show large potential, both for reaching untested populations and for substantial economies of scale as HIVST programmes scale-up and mature. From a societal perspective, the costs of HIVST appear similar to conventional HTS, with the higher providers' costs substantially offsetting user costs. Future approaches to minimizing cost and/or maximize testing coverage could include unpaid door-to-door community-led distribution to reach end-users and integrating HIVST into routine clinical services via direct or secondary distribution strategies with lower fixed costs.