Young at risk-people in Maputo City, Mozambique, present a high willingness to participate in HIV trials: Results from an HIV vaccine preparedness cohort study

Introduction Vaccine efficacy testing requires engagement of willing volunteers with high disease incidence. We evaluated factors associated with willingness to participate in potential future HIV vaccine trials in Maputo, Mozambique. Methods Adults aged 18–35 years without HIV and who reported at least two sexual partners in the 3 months prior to screening were enrolled into a 24-month observational study. They were asked at screening and exit if they would be willing to participate in a theoretical HIV vaccine study. Bivariate and multivariate logistic regression analyses were done between willingness to participate, demographic, sexual behavior, and motivational factors for screening visit data. Logistic regression with generalized estimating equations (GEE) was used to estimate odds ratios (ORs) and 95% confidence intervals (CIs) for factors potentially associated with willingness to participate for data from both visits. Results A total of 577 participants without HIV were eligible, including 275 (48%) women. The mean age was 22.2 (SD ± 3.9) years. At screening 529 (92%) expressed willingness to participate and the proportion remained stable at 378 (88%) of the 430 participants retained through the exit visit (p = 0.209). Helping the country (n = 556) and fear of needles (n = 26) were the top motive and barrier for willingness to participate, respectively. Results from the GEE binary logistic regression (screening visit and exit visit) showed that wanting to learn how to avoid risk behaviors (aOR 3.33, 95% CI: 1.61–6.86) and feeling protected against HIV infection (aOR 2.24, 95% CI: 1.07–4.7) were associated with willingness to participate in HIV vaccine studies. Conclusion The majority of our study population in Mozambique expressed willingness to participate in a theoretical HIV vaccine trial. Participation in a HIV vaccine trial was seen as a way to contribute to the fight against HIV but was associated with some unrealistic expectations such as protection against HIV. This reinforces the need for continuous mobilization and awareness of potential participants to HIV vaccine trial.

Meeting report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017

A cornerstone of HIV prevention clinical trials is providing a combination prevention package to all trial participants. The elements included in that standard of care (SoC) package evolve as new prevention modalities are developed. Pre-exposure prophylaxis (PrEP) was recommended by the World Health Organization for persons at high risk of acquiring HIV, but not all countries immediately adopted those recommendations. The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to SoC and PrEP in HIV prevention clinical trials taking place in lower- to middle-income countries (LMIC). Policymakers, regulators, ethicists, experts in law, researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. A group of subject matter experts presented on the regulatory, ethical, scientific, and historic framework of SoC in clinical trials, focusing on PrEP in South Africa. Summit participants discussed how and when to include new HIV treatment and prevention practices into existing clinical guidelines and trial protocols, as well as the opportunities for and challenges to scaling up interventions. The summit addressed challenges to PrEP provision, such as inconsistent efficacy amongst different populations and various biological, virological, and immunological explanations for this heterogeneity. Advocates and community members propagated the urgent need for accessible interventions that could avert HIV infection. The meeting recommended supporting access to PrEP in HIV prevention trials by (1) developing PrEP access plans for HIV vaccine trials, (2) creating a PrEP fund that would supply PrEP to sites conducting HIV prevention trials via a central procurement mechanism, and (3) supporting the safety monitoring of PrEP. This report summarizes the presentations and discussions from the summit in order to highlight the importance of SoC in HIV prevention clinical trials.

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

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.

Meeting Report: South African Medical Research Council Standard of Care in Clinical Research in Low- And Middle-Income Settings Summit, November 2017

Introduction: The South African Medical Research Council (SAMRC) convened a summit to discuss issues relating to standard of care (SoC) in HIV prevention clinical trials, both for treatment and prevention of disease. Policymakers, regulators, ethicists, experts in the law (as it pertains to medical research), researchers, representatives of advocacy groups, and the HIV Vaccine Trials Network (HVTN) presented a framework within which SoC principles could be articulated. Discussion: Summit participants discussed how and when to include new modalities of HIV treatment and prevention into existing clinical practice guidelines, and by extension in clinical trial protocols. Participants involved in the execution of care and the scale-up of new interventions, in particular, the roll out of pre-exposure prophylaxis (PrEP), presented the opportunities for and challenges to scaling up interventions, and their experience with demonstration projects of PrEP. Advocates and community members propagated the need to make interventions that could avert HIV infection available as soon as possible. Experts in evidence-based guideline development discussed the nuances in evaluating evidence for policy and the mechanisms for getting medicines on the Essential Medicines List in South Africa. Given the variability in clinical trial efficacy of PrEP amongst different populations, scientists and statisticians discussed the various biological, virological and immunological reasons for this heterogeneity. Conclusions: Input was given as to the impact of introducing PrEP in other HIV prevention trials, and the considerations for the design of both antiretroviral (ARV)-based and non-ARV based HIV prevention trials. The meeting recommended supporting access to PrEP in HIV prevention trials by 1) developing PrEP access plans for HIV vaccine trials; 2) creating a PrEP fund that would supply PrEP to sites conducting HIV prevention trials via a central procurement mechanism; and 3) support the safety monitoring of PrEP.

Post-HIV vaccine trials’ misperception and associated factors among participating communities in Dar es Salaam, Tanzania

Background: Despite the successful conduct of three Phase I/II HIV vaccine trials in Dar es Salaam, Tanzania, misperception around the trials has been reported. In this study, misperception means incorrect understanding that in Phase I/II HIV vaccine trial, the researchers infected the volunteers with HIV. We describe the magnitude of misperception around HIV vaccine trials and associated factors among participating communities in Dar es Salaam, Tanzania. Methods: We conducted a cross-sectional study that included 605 respondents aged ³18 years from the communities that participated in Phase I/II HIV vaccine trials. These communities comprised of youths, Police and Prison officers. Respondents were interviewed using a pre-tested questionnaire on socio-demographic characteristics, HIV knowledge, and responses to HIV vaccine trial related questions. Results: Of the 605 respondents, 156 (26%) had misperception that the researchers infected the volunteers with HIV during the trials, while 58% weren’t sure whether the researchers infected the volunteers with the HIV or not. Awareness about progress in HIV vaccine development (adjusted risk ratio (RR)=1.50; 95% CI=1.11 – 2.04), participation in an HIV vaccine sensitization meeting (adjusted RR=1.50; 95% CI=1.14-1.97) and advanced secondary education (adjusted RR=1.92; 95% CI=1.19 – 3.09) were associated with an increased likelihood of having the misperception that researchers infected the volunteers. Nevertheless, the majority (94.5%) of respondents showed a willingness to know more about ongoing HIV vaccine studies while about 44.3% had reservations of taking part in HIV vaccine trials due to fear of getting HIV from the vaccine. Conclusions: The misperception that researchers infected volunteers with HIV in Phase I/II trial is significant and was associated with respondents’ awareness about HIV vaccine development, participation in sensitization meetings and advanced education. Partial knowledge about HIV vaccine trials was of note. Future HIV vaccine trials should strive to address the knowledge gap.

Willingness to Participate in Hypothetical HIV Vaccine Trial and Associated Factors among People Who Inject Drugs in Dar es Salaam, Tanzania

This study is aimed at assessing the willingness to participate in the HIV vaccine trials and the associated factors among people who inject drugs (PWIDs) in Tanzania. Information about the willingness to participate and the associated factors was collected using interviewer-administered questionnaires at the medication treatment for opioid use disorder (MOUD) clinic in Dar es Salaam. Data analysis was performed using the IBM SPSS Statistic 20. The mean age of respondents was 36.7, and the standard deviation (SD) was ±7.2. The majority of respondents (68%) had primary education, and a high proportion of them were single (61.5%). More than one-third (37.9%) shared needles and syringes. Most (87.3%) had more than three sexual partners, and almost half (51.4%) did not use condoms during sexual intercourse with nonregular partners. About 63% had knowledge of HIV transmission while 27% had heard about HIV vaccine trials. Generally, 76% of the respondents expressed willingness to participate in future HIV vaccine trials regardless of prior knowledge of HIV vaccine trials. Willingness to participate in HIV vaccine trials was not associated with education level, people living with, knowledge about HIV transmission, awareness of HIV vaccine trials, sharing of syringe/needles, and number of sexual partners. Only older age (OR=1.6, 95%CI=1.01, 2.6) and condom use (OR=0.49, 95%CI=0.26, 0.97) showed an association with willingness. However, after performing logistic regression with factors at p value ≤ 0.2 to ascertain the other factors on the effects of age, condom use, education level, and sharing of needles/syringes, the results were not statistically significant. Although participants reported a high willingness to participate in hypothetical HIV vaccine trials, no definitive conclusion can be drawn about the associated factors. Further studies with intensive educational programs are needed to investigate the factors on willingness to participate in actual HIV vaccine trials among PWIDs.