PrEP experiences among South African women in the HPTN067 (ADAPT) study: Healthy paranoia...
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Transcript of PrEP experiences among South African women in the HPTN067 (ADAPT) study: Healthy paranoia...
PrEP experiences among South African women in the HPTN067 (ADAPT) study: Healthy paranoia
(skepticism), Ubuntu, champions and challenges to resolving PrEP dissonance
The ADAPT StudyAlternative Dosing to Augment PrEP Table Taking
K Rivet Amico, PhDUniversity of Michigan
School of Public Health
Department of Health Behavior and Health Education
On behalf of the ADAPT Study Team
• Adherence in PrEP RCTs with women in sub-Saharan 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
Background
Corneli et al., PLOS ONE 2015; Corneli et al., JAIDS 2015Van der Straten et al., JAIS 2014; Van der Straten et al., PLOS ONE 2014
ADAPT…Experiences with open-label PrEP, provided in context of explicit efforts to minimize over-reporting
• 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
Methods
179 women participants
60 qualitative participants
2 Daily arm
42 FG participants
2 Time-driven arm
2 Event-driven arm
6 Daily arm
18 IDI participants
6 Time-driven arm
6 Event-driven arm
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
Developed a framework that integrates approach to study-provided PrEP in the context of the person, community, and study.
Results – Model/Framework
Study Provided PrEP Use
Intentional Avoidance
Variable Persistence
Variable A
dherence (E
xecution)High Adherence High Persistence
Approach to Study-Provided PrEP
Context
Community-Participant-StudyDynamic
Community-Participant-StudyDynamic
Intentional Avoidance
Variable Persistence
Variable A
dherence (E
xecution)High Adherence High Persistence
Contexts
Approach to Study-Provided PrEP
• 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
Community-Participant-StudyDynamic
Community-Participant-StudyDynamic
Intentional Avoidance
Variable Persistence
Variable A
dherence (E
xecution)High Adherence High Persistence
Contexts
Approach to Study-Provided PrEP
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
Community-Participant-StudyDynamic
Community-Participant-StudyDynamic
Uncertainty
Alignm
entIntentional Avoidance
Variable Persistence
Variable A
dherence (E
xecution)High Adherence High Persistence
Contexts
Approach to Study-Provided PrEP
Distrust Mutuality
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
Community-Participant-StudyDynamic
Community-Participant-StudyDynamic
Intentional Avoidance
Variable Persistence
Variable A
dherence (E
xecution)High Adherence High Persistence
Contexts
Approach to Study-Provided PrEP
Distrust
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
Community-Participant-StudyDynamic
Community-Participant-StudyDynamic
Uncertainty
Intentional Avoidance
Variable Persistence
Variable A
dherence (E
xecution)High Adherence High Persistence
Contexts
Approach to Study-Provided PrEP
Distrust
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
Community-Participant-StudyDynamic
Community-Participant-StudyDynamic
Uncertainty
Alignm
entIntentional Avoidance
Variable Persistence
Variable A
dherence (E
xecution)High Adherence High Persistence
Contexts
Approach to Study-Provided PrEP
Distrust
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
Community-Participant-StudyDynamic
Community-Participant-StudyDynamic
Uncertainty
Alignm
entIntentional Avoidance
Variable Persistence
Variable A
dherence (E
xecution)High Adherence High Persistence
Contexts
Approach to Study-Provided PrEP
Distrust Mutuality
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
Community-Participant-StudyDynamic
Community-Participant-StudyDynamic
Uncertainty
Alignm
entIntentional Avoidance
Variable Persistence
Variable A
dherence (E
xecution)High Adherence High Persistence
Contexts
Approach to Study-Provided PrEP
Distrust Mutuality
SUPPORT STRATEGIES MUST REFLECT CURRENT DYNAMICEXAMPLES
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
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.
ACKNOWLEDGEMENTS
Gladstone Institute of Virology and Immunology
Cape Town Qualitative Team Melissa WallaceLinda-Gail BekkerSurita RouxMillicent AtujunaElaine Sebastian
Thank you