An open-label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose)

Katherine Gill, Anna-Ursula Happel, Tanya Pidwell, Andrea Mendelsohn, Menna Duyver, Leigh Johnson, Landon Meyer, Catherine Slack, Ann Strode, Eve Mendel, Lauren Fynn, Melissa Wallace, Hans Spiegel, Heather Jaspan, Jo-Ann Passmore, Sybil Hosek, Dionne Smit, Alex Rinehart, Linda-Gail Bekker, Katherine Gill, Anna-Ursula Happel, Tanya Pidwell, Andrea Mendelsohn, Menna Duyver, Leigh Johnson, Landon Meyer, Catherine Slack, Ann Strode, Eve Mendel, Lauren Fynn, Melissa Wallace, Hans Spiegel, Heather Jaspan, Jo-Ann Passmore, Sybil Hosek, Dionne Smit, Alex Rinehart, Linda-Gail Bekker

Abstract

Introduction: Young women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female-controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our understanding of acceptability, feasibility and adherence to similar modes of delivery for HIV prevention.

Methods: UChoose was an open-label randomized crossover study over 32 weeks which aimed to evaluate the acceptability and preference for contraceptive options in healthy, HIV-uninfected, female adolescents aged 15 to 19 years, as a proxy for similar HIV prevention methods. Participants were assigned to a contraceptive method for a period of 16 weeks in the form of a bi-monthly injectable contraceptive, monthly vaginal Nuvaring® or daily combined oral contraceptive (COC) and then asked to state their preference. At 16 weeks, participants crossed over to another contraceptive method, to ensure that all participants tried the Nuvaring® (least familiar modality) and additionally, either the injection or COC. Primary outcomes were contraceptive acceptability and preference. At the end of the 32 weeks they were also asked to imagine their preference for an HIV prevention modality. Secondary endpoints included changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods.

Results: Of the 180 participants screened, 130 were enrolled and randomized to the Nuvaring® (n = 45), injection (n = 45) or COC (n = 40). Significantly more Nuvaring® users (24/116; 20.7%) requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074). Of those that remained on the Nuvaring® , adherence was significantly higher than to COC (p < 0.0001). Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring® (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill.

Conclusions: Adherence to daily COC was difficult for adolescents in this cohort and the least favoured potential HIV prevention option. While some preferred vaginal ring use, these data suggest that long-acting injectables would be the preferred prevention method for adolescent girls and young women. This study highlights the need for additional options for HIV prevention in youth.

Trial registration: ClinicalTrials.gov NCT02404038.

Keywords: HIV prevention; youth; South Africa; adherence; adolescent girls; preference.

© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.

Figures

Figure 1
Figure 1
Study overview and randomization. Participants were randomized at enrolment to Nuvaring® (group A), injection (group B) or combined oral contraceptives (COC, group C). The figure indicates how many participants changed to another study arm before the crossover visit, at which all participants from group B and C were switched to Nuvaring, while participants who were previously in group A could choose their subsequent contraceptive method. LTFU, Lost to follow up. N/a, not available for ring change. *Participant was LTFU after study product change.
Figure 2
Figure 2
Contraceptive product preference. (A) Overall reported preference (n = 89) and reported preference by participants who used all study products (n = 19), Nuvaring® and injection (n = 46), or Nuvaring® and COC (n = 20). (B) Percentage of participants within one preference group (Nuvaring ® n = 34, injection n = 43 or COC n = 10) reporting reasons why they preferred this specific product are displayed in the graph.
Figure 3
Figure 3
Contraceptive adherence. (A) Self‐reported full adherence in the previous two months by injection (n = 54), Nuvaring (n = 173) and COC (n = 96) users. (B) Self‐reported reasons for non‐adherence by injection users (n = 11) in the last 2 months and Nuvaring (n = 30) and COC (n = 46) in the previous week.

References

    1. UNAIDS . UNAIDS DATA 2018 [Internet]. 2018. [cited 2020 Mar 31]. Available from:
    1. Hansoti B, Mwinnyaa G, Hahn E, Rao A, Black J, Chen V, et al. Targeting the HIV epidemic in South Africa: the need for testing and linkage to care in emergency departments. EClinicalMedicine. 2019;1(15):14–22.
    1. Gutreuter S, Igumbor E, Wabiri N, Desai M, Durand L. Improving estimates of district HIV prevalence and burden in South Africa using small area estimation techniques. PLoS One [Internet]. 2019; Feb 1 [cited 2020 Mar 31];14:e0212445 Available from:
    1. SANAC . The South African National Strategic Plan for HIV, TB and STIs. [Internet]. [cited 2020 Mar 31]. Available from:
    1. UNAIDS . UNAIDS data 2019 [Internet]. 2019. [cited 2020 Mar 31]. Available from:
    1. Sia D, Onadja Y, Hajizadeh M, Heymann SJ, Brewer TF, Nandi A. What explains gender inequalities in HIV/AIDS prevalence in sub‐Saharan Africa? Evidence from the demographic and health surveys. BMC Public Health [Internet]. 2016. Nov 3 [cited 2020 Mar 31];16(1):1–18. Available from:
    1. UNICEF . UNICEF: Working To End Aids For Every Child. Advocacy Brochure [Internet]. 2018. [cited 2020 Mar 31]. Available from:
    1. UNAIDS . UNAIDS HIV prevention among adolescent girls and young women [Internet]. 2016. [cited 2020 Mar 31]. Available from:
    1. WHO . WHO | HIV and adolescents: guidance for HIV testing and counselling and care for adolescents living with HIV [Internet] [cited 2020 Mar 31]. Available from:
    1. Okonkwo C, Anderman E, Gray D. Predicting condom negotiation efficacy in economically disadvantaged adolescents. J Prof Couns Psychother Res [internet]. 2019. Jul [cited 2020 Oct 5];1(1). Available from:
    1. Bekker LG, Gill K, Wallace M. Pre‐exposure prophylaxis for South African adolescents: What evidence? [Internet]. South Afr Med Assoc. 2015. [cited 2020 Mar 31]. 105:907–11. Available from:
    1. Glaubius R, Ding Y, Penrose KJ, Hood G, Engquist E, Mellors JW, et al. Dapivirine vaginal ring for HIV prevention: modelling health outcomes, drug resistance and cost‐effectiveness. J Int AIDS Soc. 2019;22:e25282.
    1. Fernandez C, van Halsema CL. Evaluating cabotegravir/rilpivirine long‐acting, injectable in the treatment of HIV infection: Emerging data and therapeutic potential. Vol. 11, HIV/AIDS ‐ Research and Palliative Care. Dove Medical Press Ltd.; 2019;179–92.
    1. Landovitz RJ, Li S, Grinsztejn B, Dawood H, Liu AY, Magnus M, et al. Safety, tolerability, and pharmacokinetics of long‐acting injectable cabotegravir in low‐risk HIV‐uninfected individuals: HPTN 077, a phase 2a randomized controlled trial. PLoS Med [Internet]. 2018. Nov 1 [cited 2020 Mar 31];15:e1002690 Available from:
    1. Tolley EE, Zangeneh SZ, Chau G, Eron J, Grinsztejn B, Humphries H, et al. Acceptability of Long‐Acting Injectable Cabotegravir (CAB LA) in HIV‐Uninfected Individuals: HPTN 077. AIDS Behav. 2020;24(9):2520–2531. 10.1007/s10461-020-02808-2
    1. Tolley EE, Li S, Zangeneh SZ, Atujuna M, Musara P, Justmanet J, et al. Acceptability of a long‐acting injectable HIV prevention product among US and African women: findings from a phase 2 clinical Trial (HPTN 076). J Int AIDS Soc. 2019;22:e25408.
    1. Hodges‐Mameletzis I, Fonner VA, Dalal S, Mugo N, Msimanga‐Radebe B, Baggaley R. Pre‐exposure prophylaxis for hiv prevention in women: current status and future directions. Drugs. 2019;79(12):1263–76.
    1. Eisingerich AB, Wheelock A, Gomez GB, Garnett GP, Dybul MR, Piot PK. Attitudes and acceptance of oral and parenteral HIV preexposure prophylaxis among potential user groups: a multinational study. PLoS One. 2012;7:e28238.
    1. Developing Adolescents A Reference for Professionals [Internet]. Washington, DC: American Psychological Association; 2002. [cited 2020 Mar 31]. Available from:
    1. Mathias SD, Colwell HH, LoCoco JM, Karvois DL, Pritchard ML, Friedman AJ. ORTHO birth control satisfaction assessment tool: assessing sensitivity to change and predictors of satisfaction. Contraception [Internet]. 2006. Oct [cited 2020 Mar 31];74(4):303–8. Available from:
    1. Minnis AM, Atujuna M, Browne EN, Ndwayana S, Hartmann M, Sindelo S, et al. Preferences for long‐acting Pre‐Exposure Prophylaxis (PrEP) for HIV prevention among South African youth: results of a discrete choice experiment. J Int AIDS Soc. 2020;23:e25528.
    1. Minnis AM, Browne EN, Boeri M, Agot K, van der Straten A, Ahmed K, et al. Young women's stated preferences for biomedical HIV prevention: results of a discrete choice experiment in Kenya and South Africa. J Acquir Immune Defic Syndr. 2019;80(4):394–403
    1. Kuteesa MO, Quaife M, Biraro S, Katumba KR, Seeley J, Kamali A, et al. Acceptability and predictors of uptake of anti‐retroviral pre‐exposure prophylaxis (PrEP) among fishing communities in Uganda: a cross‐sectional discrete choice experiment survey. AIDS Behav. 2019;23(10):2674–86.
    1. Bekker L, Rebe K, Venter F, Maartens G, Moorhouse M, Conradie F, et al.Southern African guidelines on the safe use of pre‐exposure prophylaxis in persons at risk of acquiring HIV‐1 infection [Internet]. Vol. 17, South African Journal of HIV Medicine. Medpharm Publications; 2016. [cited 2020 Apr 1]. 1–11. Available from:
    1. Price JT, Rosenberg NE, Vansia D, Phanga T, Bhushan NL, Maseko B, et al. Predictors of HIV, HIV risk perception, and HIV worry among adolescent girls and young women in Lilongwe, Malawi. J Acquir Immune Defic Syndr. 2018;77(1):53–63.
    1. Corneli A, Wang M, Agot K, Ahmed K, Lombaard J, Van Damme L, et al. Perception of HIV risk and adherence to a daily, investigational pill for HIV prevention in FEM‐PrEP. J Acquir Immune Defic Syndr. 2014;67(5):555–63.
    1. Haberer JE, Baeten JM, Campbell J, Wangisi J, Katabira E, Ronald A, et al. Adherence to antiretroviral prophylaxis for HIV prevention: a substudy cohort within a clinical trial of serodiscordant couples in East Africa. PLoS Med. 2013;10:e1001511.
    1. Bunge KE, Levy L, Szydlo DW, Zhang J, Gaur AH, Reirden D, et al. Brief report: phase IIa safety study of a vaginal ring containing dapivirine in adolescent young women. J Acquir Immune Defic Syndr. 2020;83(2):135–9.
    1. Van der Straten A, Agot K, Ahmed K, Weinrib R, Browne EN, Manenzhe K, et al. The Tablets, Ring, Injections as Options (TRIO) study: what young African women chose and used for future HIV and pregnancy prevention. J Int AIDS Soc. 2018;21:e25094.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren