Participants' characteristics and motivations to screen for HIV vaccine and monoclonal antibody trials in KwaZulu-Natal, South Africa

Jill Hanass-Hancock, Bradley Carpenter, Tarylee Reddy, Ayanda Nzuza, Zakir Gaffoor, Ameena Goga, Michele Andrasik, Jill Hanass-Hancock, Bradley Carpenter, Tarylee Reddy, Ayanda Nzuza, Zakir Gaffoor, Ameena Goga, Michele Andrasik

Abstract

Background: HIV is one of the greatest public health challenges in South Africa. Potential HIV vaccines and antibodies are thought to be cost-effective biomedical HIV prevention methods and are currently under investigation in phase I, II, and III trials. Consequently, current and future clinical trials need to ensure sufficient recruitment and retention. To achieve this goal, clinical trial staff need to understand the socio-demographic and behavioural characteristics of people volunteering to screen for these trials and their reasons for volunteering.

Methods: We conducted a secondary analysis of participant screening data across five vaccine and monoclonal antibody trials at four sites in KwaZulu-Natal, South Africa. Our study reviewed the demographic, behavioural, motivational, and health-related data from the case report forms and screening questionnaires. Descriptive statistics, chi-squared, and one-way ANOVA tests were used to analyse participants' characteristics and motivation to participate in HIV vaccine and monoclonal antibody trials. Analyses were conducted using R version 3.5.2.

Results: Screening data from 1934 participants, including 79.2% of women, were obtained across all five trials (1034 enrolled, 900 screened out/declined). Screened participants predominately self-identified as black, heterosexual, cisgender women or men, many with lower educational backgrounds (43.9% did not complete secondary/high school), and several self-reported HIV-risk behaviours among themselves and their partners. 10.8% of the screened participants were living with HIV. Avoiding HIV risk was the main motivation to participate in clinical trials, followed by altruistic reasons such as a desire to help the community or helping to find a vaccine.

Discussion: The current recruitment approach of these trials attracts heterosexual participants who seek to reduce HIV risk and support their community. Hence, the data suggest the need for and potential acceptance of continued ongoing HIV prevention efforts. Current trials attract participants with lower educational levels, which may be driven by the site locations, current community mobilisation strategies and research site opening hours. The sites could consider more flexible working hours to accommodate working participants and find ways to connect participants to educational support and opportunities to upgrade education levels for the current clientele.

Trial registration: HVTN 100: A Safety and Immune Response Study of 2 Experimental HIV Vaccines, NCT02404311 . Registered on March 17, 2015. HVTN 111: Safety and Immune Response to a Clade C DNA HIV Vaccine, NCT02997969. Registered on December 16, 2016. HVTN 108: Evaluating the Safety and Immunogenicity of HIV Clade C DNA Vaccine and MF59- or AS01B-Adjuvanted Clade C Env Protein Vaccines in Various Combinations in Healthy, HIV-Uninfected Adults, NCT02915016. Registered on September 22, 2016. HVTN 702: Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa, NCT02968849. Registered on November 1, 2016. HVTN 703/HPTN 081: Evaluating the Safety and Efficacy of the VRC01 Antibody in Reducing Acquisition of HIV-1 Infection in Women, NCT02568215 . Registered on October 1, 2015.

Keywords: Clinical trials; HIV prevention; HIV vaccine; HVTN; Research participation.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Motivations to participate in phase one trials. A = “I receive free counselling”; B = “I receive free HIV tests”; C = “I receive other tests or medical care for free or at no cost to me”; D = “I want to help find a vaccine that works for HIV prevention”; E = “The vaccine might protect me against HIV”; F = “I will be reimbursed or paid for being in this study”; G = “I will be informed by research” H = “It might help me to avoid high-risk behaviour”; I = “I am helping my community”; J = “I know someone who died of AIDS or who is HIV infected”

References

    1. Shisana O, Rehle T, Simbayi LC, et al. South African national HIV prevalence, incidence, behaviour and communication survey, 2008: a turning tide among teenagers? Cape Town: HSRC Press; 2009.
    1. South African National AIDS Council . National Strategic Plan on HIV, STIs and TB 2012-2016. Pretoria: SANAC; 2011.
    1. South African National AIDS Council . Let Out Actions Count. South Africa’s National Strategic Plan on HIV, TB and STIs 2017-2022. Pretoria: SANAC; 2017.
    1. Simbayi LC, Zuma K, Zungu N, et al. South African National HIV Prevalence, Incidence, Behaviour and Communication Survey, 2017. Cape Town: HSRC Press; 2019.
    1. National Department of Health (NDoH), Statistics South Africa (Stats SA), South African Medical Research Council (SAMRC) I. South Africa Demographic and Health survey 2016. Pretoria, South Africa, and Rockville, Maryland: NDoH, Stats SA, SAMRC, and ICF, 2019.
    1. Statistics South Africa . Mid-year population estimates. Pretoria: Statistics South Africa; 2020.
    1. McKinnon LR, Karim QA. Factors Driving the HIV Epidemic in Southern Africa. Curr HIV/AIDS Rep. 2016;13(3):158–169. doi: 10.1007/s11904-016-0314-z.
    1. Ramjee G, Sartorius B, Morris N, et al. A decade of sustained geographic spread of HIV infections among women in Durban, South Africa. BMC Infect Dis. 2019;19(1):500. doi: 10.1186/s12879-019-4080-6.
    1. Nel A, Mabude Z, Smit J, et al. HIV incidence remains high in KwaZulu-Natal, South Africa: evidence from three districts. PLoS One. 2012;7(4):e35278. doi: 10.1371/journal.pone.0035278.
    1. Odhiambo J. HIV vaccine clinical trials: an overview. Medical Writing. 2018;27(1):23–29.
    1. Baeten JM, Palanee-Phillips T, Brown ER, et al. Use of a Vaginal ring containing dapivirine for HIV-1 prevention in women. N Engl J Med. 2016;375(22):2121–2132. doi: 10.1056/NEJMoa1506110.
    1. Mayer KH, Ramjee G. The current status of the use of oral medication to prevent HIV transmission. Curr Opin HIV AIDS. 2015;10(4):226–232. doi: 10.1097/COH.0000000000000170.
    1. Gilbert PB, Juraska M, deCamp AC, et al. Basis and statistical design of the passive HIV-1 Antibody Mediated Prevention (AMP) test-of-concept efficacy trials. Stat Commun. Infect Dis. 2017;9(1).
    1. Bekker LG, Moodie Z, Grunenberg N, et al. Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial. Lancet HIV. 2018;5(7):e366–ee78. doi: 10.1016/S2352-3018(18)30071-7.
    1. Gray GE, Bekker LG, Laher F, et al. Vaccine efficacy of ALVAC-HIV and bivalent subtype C gp120-MF59 in adults. N Engl J Med. 2021;384(12):1089–1100. doi: 10.1056/NEJMoa2031499.
    1. McNicholl JM. Combining biomedical preventions for HIV: vaccines with pre-exposure prophylaxis, microbicides or other HIV preventions. Hum Vaccin Immunother. 2016;12(12):3202–3211. doi: 10.1080/21645515.2016.1231258.
    1. Smit J, Middelkoop K, Myer L, et al. Socio-behaviour challenges to phase III HIV vaccine trials in Sub-Saharan Africa. Afr Health Sci. 2005;5(3):198–206.
    1. Colfax G, Buchbinder S, Vamshidar G, et al. Motivations for participating in an HIV vaccine efficacy trial. J Acquir Immune Defic Syndr. 2005;39(3):359–364. doi: 10.1097/.
    1. Harper KN. HVTN100 phase 1/2 vaccine trial results promising; phase 2b/3 trial to commence. AIDS. 2017;31(2):N1–N2.
    1. Tarimo EA, Bakari M, Kakoko DC, et al. Motivations to participate in a Phase I/II HIV vaccine trial: a descriptive study from Dar es Salaam, Tanzania. BMC Public Health. 2016;16(182):182. doi: 10.1186/s12889-016-2875-6.
    1. Nyaoke BA, Mutua GN, Sajabi R, Nyasani D, Mureithi MW, Anzala OA. Volunteer motivators for participating in HIV vaccine clinical trials in Nairobi, Kenya. PLoS One. 2017;12(9):e0183788. doi: 10.1371/journal.pone.0183788.
    1. Ramjee G, Moonsamy S, Abbai NS, Wand H. Individual and population level impact of key HIV risk factors on HIV incidence rates in Durban, South Africa. PLoS One. 2016;11(4):e0153969. doi: 10.1371/journal.pone.0153969.
    1. Ramjee G, Sartorius B, Morris N, et al. A decade of sutainded geographic spread of HIV infections among women in Durban. South Africa. BMC Infectious Diseases. 2019;19(500):1–9.
    1. Bekker L, Moodie Z, Grunenberg N, et al. HVTN 100 Protocol Team. Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1/2 trial. Lancet HIV. 2018;5(7):e366–ee78. doi: 10.1016/S2352-3018(18)30071-7.
    1. Hosseinipour M, Innes C, Naidoo S, et al. Phase 1 Human immunodeficiency virus (HIV) vaccine trial to evaluate the safety and immunogenicity of HIV subtype C DNA and MF59-adjuvanted subtype C envelope protein. Clinical Infectious Diseases. 2021;72(1):50–60.
    1. Statistical Centre for HIV/AIDS Research and Prevention (SCHARP). ATLAS Scientific Portal. 2019. (accessed 15 February 2019).
    1. UNAIDS . UNAIDS Terminology Guidelines. Geneva: UNAIDS; 2015.
    1. UNAIDS, WHO . Ethical considerations in HIV prevention trials. Geneva: UNAIDS; 2021.
    1. van der Berg S, Burger C, Burger R, et al. Low quality education as a poverty trap. SSRN Electronic Journal. 2011.
    1. The Aurum Insitute. Implementation Research on HIV/AIDS at The Aurum Institute. 2019. (accessed 1 August 2019).
    1. Andrasik M, Grove D, Broder G, Scott H, Allen M, Karuna S. A descriptive analysis of transgender participants in phase 1-2a trials of the HIV Vaccine Trials Network (HVTN) in the United States and Peru. Vaccine. 2019;37(29):3911–3917. doi: 10.1016/j.vaccine.2019.05.016.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner