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




Variable A

dherence (E


Contexts


• 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





Variable A

dherence (E


Contexts


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



Uncertainty

Alignm

entIntentional Avoidance


Variable A

dherence (E


Contexts


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





Variable A

dherence (E


Contexts


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



Uncertainty



Variable A

dherence (E


Contexts


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



Uncertainty

Alignm



Variable A

dherence (E


Contexts


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



Uncertainty

Alignm



Variable A

dherence (E


Contexts


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



Uncertainty

Alignm



Variable A

dherence (E


Contexts


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

prep experiences among south african women in the hptn067 (adapt) study: healthy paranoia...

Documents

prep experiences

prep dissonancethe

prep rcts

selfadministered prep

study teamadherence

study fearsconcerns

openlabel prep

openlabel study