Willingness to participate in future HIV vaccine trials among men who have sex with men and female sex workers living in Nairobi, Kenya

Mutisya, Elizabeth Mueni; Mutua, Gaudensia; Nyasani, Delvin; Nduta, Hannah; Kabuti, Rhoda; Muturi-Kioi, Vincent; Omosa-Manyonyi, Gloria; Abaasa, Andrew; Lindan, Krysia; Price, Matt A.; Kimani, Joshua; Anzala, Aggrey O.

doi:10.1371/journal.pone.0238028

Cited by 13 publications

(20 citation statements)

References 21 publications

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“…We have previously reported results from this study demonstrating a high willingness to participate in HIV vaccine trials among members of these key populations from Nairobi, Kenya (14). Here, we report a high level of retention among study participants.…”

Section: Discussionsupporting

confidence: 61%

“…An alcohol use disorder screening test, the CAGE (29) was administered. We evaluated HIV prevention knowledge to assess both biomedical and behavioural prevention methods at the last study visit (14).…”

Section: Follow Up and Volunteer Retentionmentioning

confidence: 99%

“…Prevention of HIV infection is key to ending the pandemic (10,11). HIV prevention trials will require the inclusion of those at high risk of HIV infection (1,12,13) and their decision to take part and remain in the clinical trial to the end is important (1,14,15). Globally men who have sex with men (MSM) and female sex workers (FSW) are at a disproportionately high risk of HIV infection with a higher HIV incidence and prevalence compared to the general population (10,11).…”

Section: Introductionmentioning

confidence: 99%

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Feasibility of conducting HIV prevention trials among key populations in Nairobi, Kenya

Mutisya

Muturi-Kioi²,

Abaasa

et al. 2022

Preprint

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ObjectiveTo assess the feasibility of conducting HIV prevention trials among key populations in Nairobi, Kenya.BackgroundHIV prevention trials require the inclusion of those at high risk of HIV infection and their informed decision to take part and remain in the clinical trial to the end is crucial. In Kenya key populations including men who have sex with men (MSM) and female sex workers (FSW) are, disproportionately, at high risk of HIV infection when compared to the general population. Few trials testing biomedical prevention products against HIV have enrolled Kenyan FSW and MSM. MethodsWe performed simulated vaccine efficacy trial (SiVET) using licensed hepatitis B vaccines as substitutes for a HIV vaccine candidate and included randomization for those immune to hep B. The SiVET was an observational study designed to mimic the rigors of a clinical trial; we assessed HIV risk, provided risk counselling and prevention tools and performed HIV testing at baseline and periodically until the end of the trial. MSM and FSW were enrolled at a ratio of 4:1. Volunteers were assigned to either hepatitis B vaccine or placebo. ResultsRecruitment took approximately 24 months between Sep 2015 and Sep 2017. Of the 368 volunteers screened, 250 (200 MSM and 50 FSW) were enrolled. Reasons for exclusion at screening included: being positive for HIV (n=7), hepatitis (n = 14), other pre-existing medical conditions (n=41), eligible but chose not to enrol (n=47). Most of the volunteers adhered to study procedures and attended their study visits within the study window. These include volunteers who received the second vaccination 244 (98%), the third vaccination 228 (91%) and, the final study visit 217 (87%). The reasons volunteers discontinued from the study early included: relocation and loss to follow up (n=14). A total of 8 cases of HIV infection were observed in 174.5 Person Years at Risk (PYAR), all among MSM, including 5 seroconversions identified at the last study visit, for a HIV incidence of 4.58 cases/ 100 PYAR, among MSM enrolled in the study. ConclusionOur findings suggest that it is possible to conduct HIV prevention trials among key populations in Nairobi with a good adherence to a vaccine efficacy trial schedule. Despite HIV prevention efforts, we also noted a high incidence of HIV infection. This demonstrates the need for effective HIV prevention products in these populations.

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Section: Discussionsupporting

confidence: 61%

Section: Follow Up and Volunteer Retentionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Feasibility of conducting HIV prevention trials among key populations in Nairobi, Kenya

Mutisya

Muturi-Kioi²,

Abaasa

et al. 2022

Preprint

Self Cite

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“…Consistent with previous studies [ 7 ], we found that a fairly large proportion (36%) of participants LTFU did not attend any follow-up visit, or only attended one follow-up visit. This finding lends support to proposals for preparatory cohorts in which potential HIV prevention trial participants demonstrate availability for long-term follow-up and willingness to comply with the study visit schedules prior to enrolment [ 7 , 14 ].…”

Section: Discussionsupporting

confidence: 55%

Predictors of Loss to Follow-Up in an HIV Vaccine Preparedness Study in Masaka, Uganda

Kabarambi

Kansiime

Kusemererwa

et al. 2022

IJERPH

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Background: High participant retention is essential to achieve adequate statistical power for clinical trials. We assessed participant retention and predictors of loss to follow-up (LTFU) in an HIV vaccine-preparedness study in Masaka, Uganda. Methods: Between July 2018 and March 2021, HIV sero-negative adults (18–45 years) at high risk of HIV infection were identified through HIV counselling and testing (HCT) from sex-work hotspots along the trans-African highway and fishing communities along the shores of Lake Victoria. Study procedures included collection of baseline socio-demographic data, quarterly HCT, and 6-monthly collection of sexual risk behaviour data. Retention strategies included collection of detailed locator data, short clinic visits (1–2 h), flexible reimbursement for transport costs, immediate (≤7 days) follow-up of missed visits via phone and/or home visits, and community engagement meetings. LTFU was defined as missing ≥2 sequential study visits. Poisson regression models were used to identify baseline factors associated with LTFU. Results: 672 participants were included in this analysis. Of these, 336 (50%) were female and 390 (58%) were ≤24 years. The median follow-up time was 11 months (range: 0–31 months). A total 214 (32%) participants were LTFU over 607.8 person-years of observation (PYO), a rate of 35.2/100 PYO. LTFU was higher in younger participants (18–24 years versus 35–45 years, adjusted rate ratio (aRR) = 1.29, 95% confidence interval (CI) 0.80–2.11), although this difference was not significant. Female sex (aRR = 2.07, 95% CI, 1.51–2.84), and recreational drug use (aRR = 1.61, 95% CI, 1.12–2.34) were significantly associated with increased LTFU. Engagement in transactional sex was associated with increased LTFU (aRR = 1.36, 95% CI, 0.97–1.90) but this difference was not significant. LTFU was higher in 2020–2021 (the period of COVID-19 restrictions) compared to 2018–2019 (aRR = 1.54, 1.17–2.03). Being Muslim or other (aRR = 0.68, 95% CI 0.47–0.97) and self-identification as a sex worker (aRR = 0.47, 95% CI, 0.31–0.72) were associated with reduced LTFU. Conclusion: We observed a high LTFU rate in this cohort. LTFU was highest among women, younger persons, recreational drug users, and persons who engage in transactional sex. Efforts to design retention strategies should focus on these subpopulations.

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“…A recent study in Kenya reported a desire to receive healthcare and information about HIV were the motivating factors to participate in an HIV vaccine trial among MSM and FSW 25 . Furthermore, a review of the literature reported that retention and sexual disinhibition were the main socio-behavioural challenges for HIV vaccine efficacy trials in Sub-Saharan Africa.…”

Section: Introductionmentioning

confidence: 99%

What motivates or demotivates intravenous drug users to participate in hypothetical HIV vaccine efficacy trial? A qualitative study from urban Tanzania

Iseselo

Tarimo

Sandström

et al. 2020

EAHRJ

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Background: HIV vaccine efficacy trials require the active participation of volunteers who are committed and adherent to the study protocol. However, information about the influence of Injecting Drug Users (IDUs) to participate in HIV vaccine efficacy trials in low-income countries is inadequate. The present study explored the factors that motivate or hinder IDUs from participating in HIV vaccine efficacy trials in Dar es Salaam, Tanzania. Methods: A qualitative descriptive study design was employed among IDUs at Muhimbili National Hospital (MNH). A purposeful sampling technique was used to recruit the participants. Three (3) focus group discussions (FGDs) and 10 In-Depth Interviews (IDIs) were used to collect the data. The data from participants were audio-recorded, transcribed, and analysed using the content analysis approach. Findings: The participants reported that altruism and the desire to reduce risks of HIV infection were the motivators to participate in hypothetical HIV vaccine trials. In addition, participants reported to consult close relatives towards motivation to participate in the vaccine trial. In contrast, the perceived fear of vaccine side effects, lack of information about HIV vaccine studies, and HIV-related stigma towards participants were described as barriers to participate in the HIV vaccine trials. Conclusion: Participation in a hypothetical HIV vaccine trial among IDUs is influenced by positive and negative factors. Actual recruitment plans could be made through a better explanation of HIV vaccine trials, the expected individual and collective benefits associated with the trials. Community involvement and sensitisation is likely to enhance participation in future HIV vaccine trials in Tanzania.

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Willingness to participate in future HIV vaccine trials among men who have sex with men and female sex workers living in Nairobi, Kenya

Cited by 13 publications

References 21 publications

Feasibility of conducting HIV prevention trials among key populations in Nairobi, Kenya

Feasibility of conducting HIV prevention trials among key populations in Nairobi, Kenya

Predictors of Loss to Follow-Up in an HIV Vaccine Preparedness Study in Masaka, Uganda

What motivates or demotivates intravenous drug users to participate in hypothetical HIV vaccine efficacy trial? A qualitative study from urban Tanzania

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