the e-Poster

HIV PrEP Formulation Preference Among Women in the
Qualitative Component of the MTN-020/ASPIRE Study
Ariane 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
Figure 1: ASPIRE 6 qualitative sites in
South Africa; Uganda; Malawi, Zimbabwe
Background
MTN-020/ASPIRE Study (2012-2015)1
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:
A multi-site phase 3 trial of a dapivirine VR  Conducted at 6 ASPIRE sites in 4 countries
used monthly for a duration of 12-33
among 214 qualitative participants
months among women in South Africa,
(Figure 1).
Uganda, Zimbabwe and Malawi (N=2629).

Included exploration of preference for
Study results: 27% protection overall
various PrEP formulations in a
against HIV-1 and > 50% protection among
subsample of 71 participants receiving
women over the age of 21, who were
an exit In-Depth Interview (IDI).
more adherent to VR use.


56 mm outer diameter; 7.7 mm
cross-sectional diameter

ASPIRE Qualitative Component2
Methods
Figure 2: key attributes of product formulations

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.
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.
Frequencies of most and least preferred
products were summarized.
Results
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).
Product Preference
Components of Hypothetical Product Acceptability
Table 1: Baseline Characteristics
Short-acting (coital or daily)
TOTAL %
(N=71*)
Country
South Africa
Uganda
Malawi
Zimbabwe
Age (years)
Mean (min-max)
48% (34)
18% (13)
17% (12)
17% (12)
Some secondary school or more
79%
Married
48%
Has a primary sex partner
100%
Live births
Mean (min-max)
Long-acting (LA)
26.8 (18-42)
1.90 (0-5)
Contraceptive use at baseline
Injectable
Implant
IUD
Oral contraceptives
Sterilization
Condom use at last vaginal sex act
52%
24%
13%
8%
3%
42%
* 7 participants had seroconverted during ASPIRE prior to interview
0
20
LEAST %
40
60
80
100
MOST %
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).
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.
Limitations

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.
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.
Inconsistent presentation of products despite
visual tool; varying levels of probing.

Products administered vaginally were less favored among younger women (age <25).

Choice options for quantitative component
were not standardized.

Women’s general disinterest for unfamiliar
formulations (e.g. vaginal film and
suppository).
•

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.
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.

•

Conclusions
MTN-020/ASPIRE Study Team
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.
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).
References
1 Baeten J et al., N Engl J Med. 2016
2. Montgomery ET et al., IAS Poster #WEPEC265
3 Adapted from Mensch et al., Curr Opin HIV AIDS
2012
Acknowledgements
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.
www.mtnstopshiv.org