Stated product formulation preferences for HIV pre-exposure prophylaxis among women in the VOICE-D (MTN-003D) study

Ellen H Luecke, Helen Cheng, Kubashni Woeber, Teopista Nakyanzi, Imelda C Mudekunye-Mahaka, Ariane van der Straten, MTN-003D Study Team, Ellen H Luecke, Helen Cheng, Kubashni Woeber, Teopista Nakyanzi, Imelda C Mudekunye-Mahaka, Ariane van der Straten, MTN-003D Study Team

Abstract

Introduction: The effectiveness of HIV pre-exposure prophylaxis (PrEP) requires consistent and correct product use, thus a deeper understanding of women's stated product formulation preferences, and the correlates of those preferences, can help guide future research. VOICE-D (MTN-003D), a qualitative ancillary study conducted after the VOICE trial, retrospectively explored participants' tablet and gel use, as well as their preferences for other potential PrEP product formulations.

Methods: We conducted an analysis of quantitative and qualitative data from VOICE-D participants. During in-depth interviews, women were presented with pictures and descriptions of eight potential PrEP product formulations, including the oral tablet and vaginal gel tested in VOICE, and asked to discuss which product formulations they would prefer to use and why. Seven of the original product formulations displayed were combined into preferred product formulation categories based on exploratory factor and latent class analyses. We examined demographic and behavioural correlates of these preferred product formulation categories. In-depth interviews with participants were conducted, coded, and analysed for themes related to product preference.

Results: Of the 68 female participants who completed in-depth interviews (22 South Africa, 24 Zimbabwe, 22 Uganda), median age was 28 (range 21-41), 81% were HIV negative, and 49% were married or living with a partner. Four preferred product formulation categories were identified via exploratory factor analysis: 1) oral tablets; 2) vaginal gel; 3) injectable, implant, or vaginal ring; and 4) vaginal film or suppository. A majority of women (81%) expressed a preference for product formulations included in category 3. Characteristics significantly associated with each preferred product category differed. Attributes described by participants as being important in a preferred product formulation included duration of activity, ease of use, route of administration, clinic- versus self-administration, and degree of familiarity with product.

Conclusions: While there was interest in a variety of potential PrEP product formulations, a majority of VOICE-D participants preferred long-acting methods. More research is needed to gain insight into end-users' product formulation preference to inform messaging and market segmentation for different PrEP products and resources to invest in products that target populations are most interested in using.

Clinical trial number: NCT02358616.

Keywords: Africa; HIV prevention; oral pre-exposure prophylaxis; preferences; product delivery forms; vaginal microbicides; women.

Figures

Figure 1
Figure 1
MTN-003D stage 2 HIV prevention potential product formulation discussion card. Women were shown the discussion tool and asked “What type of product would you take, if any, for HIV prevention?”
Figure 2
Figure 2
Preferred HIV prevention product formulations. Women were presented with a card showing images of eight potential HIV prevention product formulations and selected which product formulations, if any, they would prefer to use.
Figure 3
Figure 3
Preferred product formulation categories. Women were categorized into preferred product formulation categories by expressing a preference for any of the included methods.

References

    1. HIV/AIDS JUNPo. Global report: UNAIDS report on the global AIDS epidemic. Geneva, Switzerland: UNAIDS; 2013.
    1. Baeten JM, Donnell D, Ndase P, Mugo NR, Campbell JD, Wangisi J, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399–410.
    1. Thigpen MC, Kebaabetswe PM, Paxton LA, Smith DK, Rose CE, Segolodi TM, et al. Antiretroviral preexposure prophylaxis for heterosexual HIV transmission in Botswana. N Engl J Med. 2012;367(5):423–34.
    1. Choopanya K, Martin M, Suntharasamai P, Sangkum U, Mock PA, Leethochawalit M, et al. Antiretroviral prophylaxis for HIV infection in injecting drug users in Bangkok, Thailand (the Bangkok Tenofovir Study): a randomised, double-blind, placebo-controlled Phase 3 trial. Lancet. 2013;381(9883):2083–90.
    1. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Eng J Med. 2010;363(27):2587–99.
    1. Abdool Karim Q, Abdool Karim SS, Frohlich JA, Grobler AC, Baxter C, Mansoor LE, et al. Effectiveness and safety of tenofovir gel, an antiretroviral microbicide, for the prevention of HIV infection in women. Science. 2010;329(5996):1168–74.
    1. Van Damme L, Corneli A, Ahmed K, Agot K, Lombaard J, Kapiga S, et al. Preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2012;367(5):411–22.
    1. Marrazzo JM, Ramjee G, Richardson BA, Gomez K, Mgodi N, Nair G, et al. Tenofovir-based preexposure prophylaxis for HIV infection among African women. N Engl J Med. 2015;372(6):509–18.
    1. Rees H, Delany-Morelwe S, Lombard C, editors. FACTS 001 Phase III trial of pericoital tenofovir 1% gel for HIV prevention in women. Conference on Retroviruses and Opportunistic Infections (CROI); February 23–26, 2015; Seattle, Washington.
    1. Baeten JM, Palanee-Phillips T, Brown ER, Schwartz K, Soto-Torres LE, Govender V, et al. Use of a vaginal ring containing dapivirine for HIV-1 prevention in women. N Engl J Med. 2016 [epub ahead of print]
    1. Nel A, Kapiga S, Bekker L, Devlin B, Borremans M, Rosenberg Z, et al. Safety and efficacy of dapivirine vaginal ring for HIV-1 prevention in African women. CROI 2016; February 22–25, 2016; Boston, MA. 2016.
    1. Woodsong C, Holt JD. Acceptability and preferences for vaginal dosage forms intended for prevention of HIV or HIV and pregnancy. Adv Drug Deliv Rev. 2015;92:146–54.
    1. Coly A, Gorbach PM. Microbicide acceptability research: recent findings and evolution across phases of product development. Curr Opin HIV AIDS. 2008;3(5):581–6.
    1. Nel AM, Mitchnick LB, Risha P, Muungo LT, Norick PM. Acceptability of vaginal film, soft-gel capsule, and tablet as potential microbicide delivery methods among African women. J Womens Health. 2011;20(8):1207–14.
    1. Romano J, Manning J, Hemmerling A, McGrory E, Holt BY. Prioritizing multipurpose prevention technology development and investments using a target product profile. Antiviral Res. 2013;100(Suppl):S32–8.
    1. van der Straten A, Montgomery E, Mavedzenge S, Musara P, Cheng H, Lutnick A, et al. Preference between precoital and daily use of duet® and BufferGel in Zimbabwe. AIDS Behav. 2012;16:1799–807.
    1. Minnis AM, Gandham S, Richardson BA, Guddera V, Chen BA, Salata R, et al. Adherence and acceptability in MTN 001: a randomized cross-over trial of daily oral and topical tenofovir for HIV prevention in women. AIDS Behav. 2013;17(2):737–47.
    1. Lucas J, El-Sahn M, Kong K, Kretschmer S. Assessing the potential of MPTs in Uganda, Nigeria, and South Africa: Bill and Melinda Gates Foundation. 2014.
    1. van der Straten A, Montgomery ET, Musara P, Etima J, Naidoo S, Laborde N, et al. Disclosure of pharmacokinetic drug results to understand nonadherence. AIDS. 2015;29(16):2161–71.
    1. van der Straten A, Stadler J, Montgomery E, Hartmann M, Magazi B, Mathebula F, et al. Women's experiences with oral and vaginal pre-exposure prophylaxis: the VOICE-C qualitative study in Johannesburg, South Africa. PLoS One. 2014;9(2):e89118.
    1. Vyas S, Kumaranayake L. Constructing socio-economic status indices: how to use principal components analysis. Health Policy Plann. 2006;21(6):459–68.
    1. Balkus JE, Brown E, Palanee T, Nair G, Gafoor Z, Zhang J, et al. An empiric HIV risk scoring tool to predict HIV-1 acquisition in African women. J Acquir Immune Defic Syndr. 2016 [epub ahead of print]
    1. van der Straten A, Montgomery E, Cheng H, Wegner L, Masenga G, von Mollendorf C, et al. High acceptability of a vaginal ring intended as a microbicide delivery method for HIV prevention in African Women. AIDS Behav. 2012;16(7):1775–86.
    1. van der Straten A, Panther L, Laborde N, Hoesley CJ, Cheng H, Husnik MJ, et al. Adherence and acceptability of a multidrug vaginal ring for HIV prevention in a Phase I study in the United States. AIDS Behav. 2016 [epub ahead of print]
    1. van der Straten A, Montgomery ET, Cheng H, Wegner L, Masenga G, von Mollendorf C, et al. High acceptability of a vaginal ring intended as a microbicide delivery method for HIV prevention in African women. AIDS Behav. 2012;16(7):1775–86.
    1. Gel Product Attribute Study Results Report [Internet] [cited 2015 Dec 13] Available from: : International Partnership for Microbicides 2007.
    1. Guest G, Shattuck D, Johnson L, Akumatey B, Clarke EE, Chen PL, et al. Acceptability of PrEP for HIV prevention among women at high risk for HIV. J Womens Health (Larchmt) 2010;19(4):791–8.
    1. Van der Straten A, Musara P, Etima J, Woeber K, Montgomery ET, Hartmann M, et al., editors. Disclosure of pharmacokinetic (PK) drug results promotes open discourse on non- adherence among women in VOICE. Cape Town, South Africa: HIV R4P; 2014.
    1. Musara P, Munaiwa O, Mahaka I, Mgodi NM, Hartmann M, Levy L, et al. The effect of presentation of pharmacokinetic (PK) drug results on self-reported study product adherence among VOICE participants in Zimbabwe. AIDS Res Hum Retrovir. 2014;30(Suppl 1):A42.
    1. Corneli A, Perry B, McKenna K, Agot K, Ahmed K, Taylor J, et al. Participants’ explanations for nonadherence in the FEM-PrEP clinical trial. J Acquir Immune Defic Syndr. 2016;71(4):452–61.
    1. Koester KA, Liu A, Eden C, Amico KR, McMahan V, Goicochea P, et al. Acceptability of drug detection monitoring among participants in an open-label pre-exposure prophylaxis study. AIDS Care. 2015;27(10):1199–204.
    1. Greene E, Batona G, Hallad J, Johnson S, Neema S, Tolley EE. Acceptability and adherence of a candidate microbicide gel among high-risk women in Africa and India. Cult Health Sex. 2010;12(7):739–54.
    1. Minnis AM, Shiboski SC, Padian NS. Barrier contraceptive method acceptability and choice are not reliable indicators of use. Sex Transm Dis. 2003;30(7):556–61.
    1. Severy LJ, Tolley E, Woodsong C, Guest G. A framework for examining the sustained acceptability of microbicides. AIDS Behav. 2005;9(1):121–31.
    1. Mensch BS, van der Straten A, Katzen LL. Acceptability in microbicide and PrEP trials: current status and a reconceptualization. Curr Opin HIV AIDS. 2012;7(6):534–41.

Source: PubMed

Sponsorit ja yhteistyökumppanit

Sairaudet

Huumeiden interventiot

3
Tilaa