Ortblad, K, Musoke, DK, Ngabirano, T, Oldenburg, C and Bärnighausen, T, 2018 Direct provision versus facility collection: a randomized controlled health systems trial of HIV self-testing among female sex workers in Uganda, 3ie Grantee Final Report. New Delhi: International Initiative for Impact Evaluation (3ie)
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An established network of trained FSW peer educators distribute oral HIV self-testing (HIVST) kits to increase rates of HIV testing, knowledge of HIV status, and feelings of empowerment among FSWs based in Kampala.
The estimated HIV prevalence among the Ugandan FSWs is five times more than that of Ugandan general population. A number of reasons, including violence, stigma, and engaging in higher-risk behaviours increase the risk of contracting HIV for FSWs. Thus, FSWs need to take adequate measures to protect themselves and their sexual partners, such as HIVST kits, private health facilities, and peer educator networks.
The evaluation explores whether the HIVST intervention will:
- increase rates of recent HIV testing among FSWs
- enhance knowledge of HIV status among FSWs
- empower FSWs to demand the use of HIV prevention measure with their sexual partners
The study design was a 1:1:1 cluster randomized controlled trial implemented in Kampala. FSW peer educator groups (one peer educator, about eight FSWs) were randomised into one of three study arms: (1) direct provision of HIV self-tests, (2) provision of coupons for free facility collection of HIV self-tests, and (3) standard-of-care HIV testing. All study arm received four peer educator visits, including condom distribution and referral to free HIV testing services. In the HIV self-testing interventions arms, peer educators additionally distributed HIV self-tests/coupons at the first and fourth peer educator visit (three months apart). Participants in the facility collection arm could exchange their HIV self-test coupon for a physical test at the ten Kampala-based participating healthcare facilities.
Theory of change
Study authors hypothesised that HIV self-testing would increase HIV testing among FSWs because it may address some of their often cited barrier to HIV testing. The direct provision of HIV self-tests to FSWs reduces barriers because FSWs to not have to travel to health facilities, arrive during facility hours, or interact with a healthcare provider. Facility-based collection of HIV self-tests still enables FSWs to freely choose the time and place of testing, but they must travel to a healthcare facility during opening hours to collect the self-test.
The same barriers that may have prevented FSWs from testing at healthcare facilities remain in the presence of HIV self-testing when it comes to linkage to care. For this reason, the authors hypothesised that linkage to care would be lower among participants who received one of the HIV self-testing interventions compared to those who tested at standard healthcare facilities. The direct provision of HIV self-tests to FSWs decouples HIV testing from the healthcare system where counselling and HIV treatment services are provided. Without counselling and proximity to HIV treatment services, mental distress may be more common and linkage to care may be delayed. The authors further hypothesised that participants who received HIV self-tests directly would be less likely to link to care than those who collected self-tests from healthcare facilities because, unlike those who had to collect self-tests, they did not have to overcome some potential barriers to accessing healthcare facilities.
Peer educator-participant groups were randomised 1:1:1 to one of three study arms. The assignment to study arms was not masked. Sealed randomisation envelopes were opened by a peer educator and research assistant after all eight participants were enrolled to a peer educator group. Research assistants, peer educators, and participants were not aware of study arm assignment prior to opening the randomisation card. The pre-specified analysis was a mixed-effect multilevel regression model with a peer educator random effect. Authors calculated risk ratios for all primary and secondary outcomes using mixed-effects linear models (Poisson distribution, log link, robust standard errors) (Zou, 2004) with a study arm fixed effect and peer educator random effect.
The trial found that compared to standard HIV testing and counseling services, HIVST increased rates of overall and repeat HIV testing in both the direct provision and facility collection arms compared to standard of care (Overall at one month: Direct 95.2%; Facility 80.4%; SOC (71.5%. Repeat at four months: Direct 87.0%; Facility 71.4%; SOC 57.6%)). The study also found that the HIVST delivery model mattered. Participants in the direct provision arm were 1.18 times more likely to test for HIV in the past month compared to facility collection (p=0.001), and 1.33 times more likely compare to standard of care (p<0.001). There were no statistical differences in linkage to care across study arms.
Cost efficiency analysis
The cost per participant in the standard-of-care arm was USD30 At ~USD7 per self-test (what the study authors paid for self-tests), the cost per participant in the direct provision arm was USD44 = and the cost per participant in the facility collection arm was USD46 The facility collection arm cost more than the direct provision arm because of additional costs supporting the healthcare facilities involved in the study and the minimal cost of coupons.
Implications for implementers
One commonly identified threat of HIV self-testing among FSWs was mistrust of the testing technology. Thus, it may be especially important to distribute HIV self-tests via trusted FSW social networks, such as peer educators, to ensure rumours do not spread that prevent FSWs from using it. It will also be important to clarify the period in which the HIV self-test can detect HIV infection and any misconceptions about oral fluid and HIV transmission during any pre-test training sessions.
Implications for policy and practice
HIV self-testing, compared to standard HIV testing and counselling services, increases universal and frequent HIV testing among Kampala-based FSWs without negatively affecting linkage to care outcomes. The uncertainty in linkage to care outcomes, however, was large, thus linkage to care following HIV self-testing remains an important concern when rolling-out national HIV self-testing interventions.
This study did not measure the effect of HIV self-testing in the absence of FSW peer educators who encouraged all participants to test for HIV. It may be difficult to generalize study results to other Sub-Saharan African settings that have less developed peer educator networks and fewer free HIV testing services for FSWs.
Implications for further research
This study, only explored the effect of HIV self-testing among FSWs when given to them for personal use. In the future, FSWs could be given more than one HIV self-test to distribute to clients, other sexual partners, friends and family members. This distribution might allow us to access individuals who might not have otherwise travelled to healthcare facilities to test for HIV or selected to test for HIV in front of other individuals.
This study informed the Uganda HIV self-testing strategy. The authors contributed to writing and advising on the strategy. The new strategy will be released shortly (as of May 2018).