Transcript Dynamics

PrEP experiences among South African women in the
HPTN067 (ADAPT) study: Healthy paranoia
(skepticism), Ubuntu, champions and challenges to
resolving PrEP dissonance
The ADAPT Study
Alternative Dosing to Augment PrEP Table Taking
K Rivet Amico, PhD
University of Michigan
School of Public Health
Department of Health Behavior and Health Education
On behalf of the ADAPT Study Team
Background
• Adherence in PrEP RCTs with women in subSaharan Africa had mixed results
– Some with very low product use by drug levels
• High rates of self-reported product use
• Subsequent work highlights dynamic facilitators
and barriers
– Several of which relate to context of RCT and use of
drug of unknown efficacy
ADAPT…Experiences
with
open-label
Corneli et al., PLOS ONE 2015; Corneli et al.,
JAIDS 2015
Van der Straten et al., JAIS 2014; Van der Straten et al., PLOS ONE 2014
PrEP, provided in context of explicit
efforts to minimize over-reporting
Methods
179 women
participants
60 qualitative
participants
42 FG
participants
18 IDI
participants
2 Daily arm
6 Daily arm
2 Time-driven
arm
6 Time-driven
arm
2 Event-driven
arm
6 Event-driven
arm
• Average age 26, range 18-52
• On self-administered PrEP for
24 weeks
• Qualitative data collected
within 3-months of final study
visit
• Invited to participate in FG or
IDI in two waves (first and last
half of project)
• Mixed convenience (FG) and
targeted (IDIs) sampling
• Themes identified with
framework analysis
Results – THEMES
•
•
•
•
[Poster #TUPEC515]
Facilitators of PrEP use
Challenges to PrEP use
Facilitators of participation
Erosion of engagement
Results – THEMES
• High value on reciprocity to community (Ubuntu)
• Healthy Skepticism (self, community)
– Fears/concerns about PrEP provided by study
– Fears/concerns about integrity/trustworthiness of
trial/procedures
– Influence of community, important others, and fellow
participants on amplifying concerns
• Variable approaches to product use
– Active avoidance
– Champions
Results – Model/Framework
Developed a framework that integrates approach to
study-provided PrEP in the context of the person,
community, and study.
Study Provided PrEP Use
Variable Adherence
(Execution)
Intentional Avoidance
High Adherence
High Persistence
Approach to Study-Provided PrEP
Context
Contexts
Variable Adherence
(Execution)
Intentional Avoidance
Community-Participant-Study
Dynamic
•
•
•
•
•
High Adherence
High Persistence
Approach to Study-Provided PrEP
Community-Participant-Study
Dynamic
Value of social and personal resources afforded through participation
Social-Political History with biomedical research and medical institutions
Identity attributes as participant or product user (internally, to important others, in the community)
Cultural world view emphasizing reciprocity
Product attributes Regimen Burden, Ease of use, Match to context
Dynamics
Contexts
Variable Adherence
(Execution)
Intentional Avoidance
Community-Participant-Study
Dynamic
High Adherence
High Persistence
Approach to Study-Provided PrEP
Community-Participant-Study
Dynamic
Dynamics – Different ways people negotiate tensions and synergies
between community, self, and study/product
• Produce different approaches to study provided PrEP
• Have unique implications for intervention
• Depends heavily on alignment with study
Model of Mutuality
Contexts
Alignment
Variable Adherence
(Execution)
Distrust
Intentional Avoidance
Community-Participant-Study
Dynamic
High Adherence
High Persistence
Approach to Study-Provided PrEP
Mutuality
Community-Participant-Study
Dynamic
Model identifies 4 unique dynamics ranging from distrust to mutuality
-Explain unique characteristics of each dynamic
-Associated approach to PrEP
-A excerpt highlighting an important aspect of the dynamic
Model of Mutuality-Distrust
Contexts
Variable Adherence
(Execution)
Distrust
Intentional Avoidance
Community-Participant-Study
Dynamic
High Adherence
High Persistence
Approach to Study-Provided PrEP
Community-Participant-Study
Dynamic
Rejection of product safety, integrity of study, and potential
reciprocity to community
Intentional Avoidance of use of PrEP (and disclosure)
“… I will never drink these pills because I don't trust them…” -T IDI
Model of Mutuality- Uncertainty
Contexts
Variable Adherence
(Execution)
Distrust
Intentional Avoidance
Community-Participant-Study
Dynamic
High Adherence
High Persistence
Approach to Study-Provided PrEP
Community-Participant-Study
Dynamic
Cautious exploration- not yet sure either way
Variable persistence with PrEP
“…I was getting confused and pressured because I did not know whether
to continue take tablets or not.”-- D IDI
Model of Mutuality- Alignment
Contexts
Alignment
Variable Adherence
(Execution)
Distrust
Intentional Avoidance
Community-Participant-Study
Dynamic
High Adherence
High Persistence
Approach to Study-Provided PrEP
Community-Participant-Study
Dynamic
Provisional acceptance- committed to try
Good persistence/Variable adherence to PrEP
“… I wouldn’t do any of that [not take the tablets] because I want to see if
these pills really, really work” -- T FG
Model of Mutuality - Mutuality
Contexts
Alignment
Variable Adherence
(Execution)
Distrust
Intentional Avoidance
Community-Participant-Study
Dynamic
High Adherence
High Persistence
Approach to Study-Provided PrEP
Mutuality
Community-Participant-Study
Dynamic
Ownership/Advocacy- Champions
Good persistence/Good adherence to PrEP
“… and I said: “Look here, ask me. And don’t you dare say I have HIV,
telling everyone in this shop. We are doing research here… to see whether
the pills can protect someone from HIV.” -- E FG
Model of Mutuality
Contexts
Alignment
Variable Adherence
(Execution)
Distrust
Intentional Avoidance
Community-Participant-Study
Dynamic
High Adherence
High Persistence
Approach to Study-Provided PrEP
Mutuality
Community-Participant-Study
Dynamic
SUPPORT STRATEGIES MUST REFLECT CURRENT DYNAMIC
EXAMPLES
1:1 targeting of barriers to execution adherence not relevant in DISTRUST and could promote staying in
that dynamic
Messaging on importance of adherence may be disempowering in the MUTUALITY dynamic
Recommendations
• Do not assume participants enter a study ‘neutral’ in
beliefs or trust of study
• Products (and studies) need to prove themselves as
valuable, safe and trustworthy
– Need creative, engaging community focused ways to
• integrate community into research- CBPR practices
• promote exploration and decision making around
product use
• enhance trust in trials and reciprocity for contributions
Limitations
• Model based on qualitative discourse in a specific
cohort. Cannot assume generalizability to other groups
or “real world” PrEP use.
• Model is a proposed framework
– Requires validation and measures of mutuality
dynamics
Conclusions
• The proposed mutuality model offers a framework for
understanding intersections of community, participant
and study
– Consistent with findings in other work in this area
– Synergistic with models of community participatory and action
based research
• Product-use and PrEP-use occurs in context where
safety and beliefs about benefits to self and
community are necessary preliminary conditions for
optimal uptake and use to have a chance to occur
ACKNOWLEDGEMENTS
The HIV Prevention Trials Network is sponsored by the
National Institute of Allergy and Infectious Diseases,
the National Institute of Mental Health, and the National
Institute on Drug Abuse, all components of the
U.S. National Institutes of Health.
Gladstone Institute
of Virology and
Immunology
Thank you
Cape Town Qualitative Team
Melissa Wallace
Linda-Gail Bekker
Surita Roux
Millicent Atujuna
Elaine Sebastian