HIV PrEP Formulation Preference Among Women in the

Qualitative Component of the MTN-020/ASPIRE StudyAriane van der Straten1,7, Mary Kate Shapley-Quinn1, Krishnaveni Reddy2 , Helen Cheng1, Juliane Etima3, Kubashni Woeber4, Petina Musara5,

Thesla Palanee-Phillips2, Jared Baeten6, Elizabeth T. Montgomery1 on behalf of the MTN-020/ASPIRE study team

1Women’s Global Health Imperative (WGHI) RTI International, San Francisco, CA, USA; 2 Wits Reproductive Health and HIV Institute (Wits RHI), Johannesburg, South Africa; 3Makerere University – Johns Hopkins University Research Collaboration, Kampala, Uganda; 4Medical Research Council, Durban, South Africa; 5UZ-UCSF Collaborative Research

Programme, Harare, Zimbabwe; 6University of Washington, Seattle, WA, USA; 7Center for AIDS Prevention Studies (CAPS), University of California San Francisco, CA, USA

We are grateful to the women who participated in the ASPIRE qualitative study, to the study staff, to the communities who partnered with us to conduct the trial, and to all of our collaborators.

The Microbicide Trials Network is funded by the National Institute of Allergy and Infectious Diseases (UM1AI068633, UM1AI068615, UM1AI106707), with co-funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all components of the U.S. National Institutes of Health. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Background

Methods During Exit IDI, participants were…

• Presented with pictures and brief descriptions of nine potential PrEP product formulations (Figure 2) – including VR and male condoms provided in ASPIRE.

• Asked to select most and least preferred products and explain their choice(s), including what attributes of the product were (un)appealing compared to others.

• Frequencies of most and least preferred products were summarized.

Results

Other Factors Influencing Preference

Age: younger (<25 years old) had greater dislike for vaginal products - aside from ring.

Clinic context:

• Less frequent visits preferred.

• Confidence in clinic staff: concerns about staff unqualified to administer products (e.g. injection, implant) or performing an “invasive” procedure (e.g. insert ring) vs. valued staff-administration (e.g. users not trustable, clinic seen as more hygienic for infection control).

Local contraceptive method mix:

• Familiarity from direct experience with some methods (injection, pill, condoms).

• Norms and rumors about locally available contraceptive methods strongly influenced opinions about potential HIV product formulations.

Stigma: oral pills associated by some with HIV treatment (ARV) or being sick.

Figure 4: Most and least preferred HIV prevention formulations. Women were presented with 9 products on the visual tool & selected which products, if any, were the most and least appealing to them. Median number of products selected as “most” or “least” appealing was 2 (ranged 0-8).

Limitations Duration of protection, low user burden, and discreetness were favored attributes of

long-acting formulations. However, the appeal for injections or implants was mitigated by concerns with pain upon administration, invasiveness, low reversibility and potential toxicity.

Being tedious to use and unreliable/easy to forget were salient unfavorable attributes for short-acting (daily & coital) products.

For several participants high product efficacy (hypothetical or real) trumped formulation.

Products administered vaginally were less favored among younger women (age <25).

• For the ring, dislike for vaginal administration was mitigated by infrequent (monthly) re-administration, perceived safety, lack of side effects, familiarity, comfort and discretion once in place.

Knowledge of contraceptive methods (based on perceptions or experience) influenced formulation and attribute preferences for HIV prevention.

Conclusions

Vaginal ring (VR):

Allows sustained delivery of microbicides for ≥ 1 month

Contains 25 mg NNRTI Dapivirine formulated in a silicone elastomer matrix ring developed by IPM:

56 mm outer diameter; 7.7 mm cross-sectional diameter

References1 Baeten J et al., N Engl J Med. 2016 2. Montgomery ET et al., IAS Poster #WEPEC2653 Adapted from Mensch et al., Curr Opin HIV AIDS 2012

Acknowledgements

MTN-020/ASPIRE Study (2012-2015)1

A multi-site phase 3 trial of a dapivirine VR used monthly for a duration of 12-33 months among women in South Africa, Uganda, Zimbabwe and Malawi (N=2629).

Study results: 27% protection overall against HIV-1 and > 50% protection among women over the age of 21, who were more adherent to VR use.

ASPIRE Qualitative Component2

Conducted at 6 ASPIRE sites in 4 countries among 214 qualitative participants (Figure 1).

Included exploration of preference for various PrEP formulations in a subsample of 71 participants receiving an exit In-Depth Interview (IDI).

Using NVivo software, textual data from IDI were coded and concatenated into reports by thematic area (e.g. PREFERENCE), then summarized into memos.

Memos were analyzed to reveal salient topics, using an adapted acceptability conceptual model3 (Figure 3).

* 7 participants had seroconverted during ASPIRE prior to interview

TOTAL % (N=71*)

CountrySouth Africa

Uganda Malawi

Zimbabwe

48% (34)18% (13)17% (12)17% (12)

Age (years)Mean (min-max) 26.8 (18-42)

Some secondary school or more 79%

Married 48%

Has a primary sex partner 100%

Live births Mean (min-max)

1.90 (0-5)

Contraceptive use at baseline Injectable

ImplantIUD

Oral contraceptivesSterilization

52%24%13%8%3%

Condom use at last vaginal sex act 42%

0 20 40 60 80 100

LEAST % MOST %

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Components of Hypothetical Product AcceptabilityProduct Preference

Key Attributes of Product Formulations: Vaginal Gel: vaginally administered using an applicator, inserted daily or pericoitally; Oral Tablets: orally administered, used daily, already proven to protect against HIV; Injectables: injected using a needle, administered once every two-three months; Vaginal Film: vaginally administered using fingers, inserted daily or pericoitally; Vaginal Ring: vaginally administered using fingers, replaced once a month or less frequently (once every three months); Male & Female Condoms: male condoms applied using finger, female condoms vaginally inserted using fingers, both used coitally, already proven to protect against HIV; Vaginal Suppository/Tablets: vaginally administered using finger or an applicator, inserted daily or pericoitally; Implants: flexible plastic rods placed under the skin of the upper arm; for contraception, implants are inserted every 3-5 years.

www.mtnstopshiv.org

MTN-020/ASPIRE Study Team

Study Team Leadership: Jared Baeten, University of Washington

(Protocol Chair); Thesla Palanee-Phillips, Wits Reproductive

Health and HIV Institute (Protocol Co-chair); Elizabeth Brown, Fred

Hutchinson Cancer Research Center (Protocol Statistician); Lydia

Soto-Torres, US National Institute of Allergy and Infectious

Diseases (Medical Officer); Katie Schwartz, FHI 360 (Clinical

Research Manager)

Study sites and site Investigators of Record:

Malawi, Blantyre site (Johns Hopkins University, Queen Elizabeth

Hospital): Bonus Makanani; Malawi, Lilongwe site (University of

North Carolina, Chapel Hill): Francis Martinson; South Africa, Cape

Town site (University of Cape Town): Linda-Gail Bekker; South

Africa, Durban – Botha’s Hill, Chatsworth, Isipingo, Tongaat,

Umkomaas, Verulam sites (South African Medical Research

Council): Vaneshree Govender, Samantha Siva, Zakir Gaffoor,

Logashvari Naidoo, Arendevi Pather, and Nitesha Jeenarain; South

Africa, Durban, eThekwini site (Center for the AIDS Programme for

Research in South Africa): Gonasagrie Nair; South Africa,

Johannesburg site (Wits RHI): Thesla Palanee-Phillips; Uganda,

Kampala site (John Hopkins University, Makerere University):

Flavia Matovu; Zimbabwe, Chitungwiza, Seke South and Zengeza

sites (University of Zimbabwe, University of California San

Francisco): Nyaradzo Mgodi; Zimbabwe, Harare, Spilhaus site

(University of Zimbabwe, University of California San Francisco):

Felix Mhlanga.

Data management was provided by The Statistical Center for HIV/AIDS Research & Prevention (Fred Hutchinson Cancer Research Center, Seattle, WA) and site laboratory oversight was provided by the Microbicide Trials Network Laboratory Center (Pittsburgh, PA).

Figure 2: key attributes of product formulations

Figure 1: ASPIRE 6 qualitative sites in South Africa; Uganda; Malawi, Zimbabwe

Table 1: Baseline Characteristics

Vaginal Ring trial → positive bias towards ring.

• Familiarity bias due to trial participation.

• Social desirability bias towards ASPIRE staff.

• Order bias: Question on formulation preferences followed those about interest in joining future ring study.

Inconsistent presentation of products despite visual tool; varying levels of probing.

Choice options for quantitative component were not standardized.

Women’s general disinterest for unfamiliar formulations (e.g. vaginal film and suppository).