Experiences with HPTN 067/ADAPT Study-Provided Open-Label PrEP Among Women in Cape Town: Facilitators and Barriers Within a Mutuality Framework.
Identifieur interne : 000D94 ( PubMed/Curation ); précédent : 000D93; suivant : 000D95Experiences with HPTN 067/ADAPT Study-Provided Open-Label PrEP Among Women in Cape Town: Facilitators and Barriers Within a Mutuality Framework.
Auteurs : K Rivet Amico [États-Unis] ; Melissa Wallace [Afrique du Sud] ; Linda-Gail Bekker [Afrique du Sud] ; Surita Roux [Afrique du Sud] ; Millicent Atujuna [Afrique du Sud] ; Elaine Sebastian [Afrique du Sud] ; Bonnie J. Dye [États-Unis] ; Vanessa Elharrar [États-Unis] ; Robert M. Grant [États-Unis]Source :
- AIDS and behavior [ 1573-3254 ] ; 2017.
Abstract
Placebo-controlled trials of pre-exposure prophylaxis (PrEP) have reported challenges with study-product uptake and use, with the greatest challenges reported in studies with young women in sub-Saharan Africa. We conducted a qualitative sub-study to explore experiences with open-label PrEP among young women in Cape Town, South Africa participating in HTPN 067/Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking (ADAPT). HPTN 067/ADAPT provided open label oral FTC/TDF PrEP to young women in Cape Town, South Africa who were randomized to daily and non-daily PrEP regimens. Following completion of study participation, women were invited into a qualitative sub-study including focus groups and in-depth interviews. Interviews and groups followed a semi-structured guide, were recorded, transcribed, and translated to English from isiXhosa, and coded using framework analysis. Sixty of the 179 women enrolled in HPTN 067/ADAPT participated in either a focus group (six groups for a total of 42 participants) or an in-depth interview (n = 18). This sample of mostly young, unmarried women identified facilitators of and barriers to PrEP use, as well as factors influencing study participation. Cross-cutting themes characterizing discourse suggested that women placed high value on contributing to the well-being of one's community (Ubuntu), experienced a degree of skepticism towards PrEP and the study more generally, and reported a wide range of approaches towards PrEP (ranging from active avoidance to high levels of persistence and adherence). A Mutuality Framework is proposed that identifies four dynamics (distrust, uncertainty, alignment, and mutuality) that represent distinct interactions between self, community and study and serve to contextualize women's experiences. Implications for better understanding PrEP use, and non-use, and intervention opportunities are discussed. In this sample of women, PrEP use in the context of an open-label research trial was heavily influenced by underlying beliefs about safety, reciprocity of contributions to community, and trust in transparency and integrity of the research. Greater attention to factors positioning women in the different dynamics of the proposed Mutuality Framework could direct intervention approaches in clinical trials, as well as open-label PrEP scale-up.
DOI: 10.1007/s10461-016-1458-y
PubMed: 27317411
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Dye</name><affiliation wicri:level="1"><nlm:affiliation>FHI 360, Durham, NC, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>FHI 360, Durham, NC</wicri:regionArea></affiliation></author><author><name sortKey="Elharrar, Vanessa" sort="Elharrar, Vanessa" uniqKey="Elharrar V" first="Vanessa" last="Elharrar">Vanessa Elharrar</name><affiliation wicri:level="1"><nlm:affiliation>Clinical Prevention Research Branch, PSP/DAIDS/NIAID/NIH, Bethesda, MD, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Clinical Prevention Research Branch, PSP/DAIDS/NIAID/NIH, Bethesda, MD</wicri:regionArea></affiliation></author><author><name sortKey="Grant, Robert M" sort="Grant, Robert M" uniqKey="Grant R" first="Robert M" last="Grant">Robert M. Grant</name><affiliation wicri:level="1"><nlm:affiliation>Gladstone Institutes, San Francisco AIDS Foundation, University of California, San Francisco, CA, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Gladstone Institutes, San Francisco AIDS Foundation, University of California, San Francisco, CA</wicri:regionArea></affiliation></author></analytic><series><title level="j">AIDS and behavior</title><idno type="eISSN">1573-3254</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Placebo-controlled trials of pre-exposure prophylaxis (PrEP) have reported challenges with study-product uptake and use, with the greatest challenges reported in studies with young women in sub-Saharan Africa. We conducted a qualitative sub-study to explore experiences with open-label PrEP among young women in Cape Town, South Africa participating in HTPN 067/Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking (ADAPT). HPTN 067/ADAPT provided open label oral FTC/TDF PrEP to young women in Cape Town, South Africa who were randomized to daily and non-daily PrEP regimens. Following completion of study participation, women were invited into a qualitative sub-study including focus groups and in-depth interviews. Interviews and groups followed a semi-structured guide, were recorded, transcribed, and translated to English from isiXhosa, and coded using framework analysis. Sixty of the 179 women enrolled in HPTN 067/ADAPT participated in either a focus group (six groups for a total of 42 participants) or an in-depth interview (n = 18). This sample of mostly young, unmarried women identified facilitators of and barriers to PrEP use, as well as factors influencing study participation. Cross-cutting themes characterizing discourse suggested that women placed high value on contributing to the well-being of one's community (Ubuntu), experienced a degree of skepticism towards PrEP and the study more generally, and reported a wide range of approaches towards PrEP (ranging from active avoidance to high levels of persistence and adherence). A Mutuality Framework is proposed that identifies four dynamics (distrust, uncertainty, alignment, and mutuality) that represent distinct interactions between self, community and study and serve to contextualize women's experiences. Implications for better understanding PrEP use, and non-use, and intervention opportunities are discussed. In this sample of women, PrEP use in the context of an open-label research trial was heavily influenced by underlying beliefs about safety, reciprocity of contributions to community, and trust in transparency and integrity of the research. Greater attention to factors positioning women in the different dynamics of the proposed Mutuality Framework could direct intervention approaches in clinical trials, as well as open-label PrEP scale-up.</div></front></TEI><pubmed><MedlineCitation Status="In-Process" Owner="NLM"><PMID Version="1">27317411</PMID><DateCreated><Year>2016</Year><Month>06</Month><Day>18</Day></DateCreated><DateRevised><Year>2017</Year><Month>04</Month><Day>18</Day></DateRevised><Article PubModel="Print"><Journal><ISSN IssnType="Electronic">1573-3254</ISSN><JournalIssue CitedMedium="Internet"><Volume>21</Volume><Issue>5</Issue><PubDate><Year>2017</Year><Month>May</Month></PubDate></JournalIssue><Title>AIDS and behavior</Title><ISOAbbreviation>AIDS Behav</ISOAbbreviation></Journal><ArticleTitle>Experiences with HPTN 067/ADAPT Study-Provided Open-Label PrEP Among Women in Cape Town: Facilitators and Barriers Within a Mutuality Framework.</ArticleTitle><Pagination><MedlinePgn>1361-1375</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1007/s10461-016-1458-y</ELocationID><Abstract><AbstractText>Placebo-controlled trials of pre-exposure prophylaxis (PrEP) have reported challenges with study-product uptake and use, with the greatest challenges reported in studies with young women in sub-Saharan Africa. We conducted a qualitative sub-study to explore experiences with open-label PrEP among young women in Cape Town, South Africa participating in HTPN 067/Alternative Dosing to Augment Pre-Exposure Prophylaxis Pill Taking (ADAPT). HPTN 067/ADAPT provided open label oral FTC/TDF PrEP to young women in Cape Town, South Africa who were randomized to daily and non-daily PrEP regimens. Following completion of study participation, women were invited into a qualitative sub-study including focus groups and in-depth interviews. Interviews and groups followed a semi-structured guide, were recorded, transcribed, and translated to English from isiXhosa, and coded using framework analysis. Sixty of the 179 women enrolled in HPTN 067/ADAPT participated in either a focus group (six groups for a total of 42 participants) or an in-depth interview (n = 18). This sample of mostly young, unmarried women identified facilitators of and barriers to PrEP use, as well as factors influencing study participation. Cross-cutting themes characterizing discourse suggested that women placed high value on contributing to the well-being of one's community (Ubuntu), experienced a degree of skepticism towards PrEP and the study more generally, and reported a wide range of approaches towards PrEP (ranging from active avoidance to high levels of persistence and adherence). A Mutuality Framework is proposed that identifies four dynamics (distrust, uncertainty, alignment, and mutuality) that represent distinct interactions between self, community and study and serve to contextualize women's experiences. Implications for better understanding PrEP use, and non-use, and intervention opportunities are discussed. In this sample of women, PrEP use in the context of an open-label research trial was heavily influenced by underlying beliefs about safety, reciprocity of contributions to community, and trust in transparency and integrity of the research. Greater attention to factors positioning women in the different dynamics of the proposed Mutuality Framework could direct intervention approaches in clinical trials, as well as open-label PrEP scale-up.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Amico</LastName><ForeName>K Rivet</ForeName><Initials>KR</Initials><AffiliationInfo><Affiliation>Department of Health Behavior and Health Education, University of Michigan, Ann Arbor, MI, USA. ramico@umich.edu.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wallace</LastName><ForeName>Melissa</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>The Desmond Tutu HIV Centre, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bekker</LastName><ForeName>Linda-Gail</ForeName><Initials>LG</Initials><AffiliationInfo><Affiliation>Dept of Medicine and Institute of Infectious Disease and Molecular Medicine, The Desmond Tutu HIV Centre, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Roux</LastName><ForeName>Surita</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>The Desmond Tutu HIV Centre, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Atujuna</LastName><ForeName>Millicent</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>The Desmond Tutu HIV Centre, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sebastian</LastName><ForeName>Elaine</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>The Desmond Tutu HIV Centre, Cape Town, South Africa.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dye</LastName><ForeName>Bonnie J</ForeName><Initials>BJ</Initials><AffiliationInfo><Affiliation>FHI 360, Durham, NC, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Elharrar</LastName><ForeName>Vanessa</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>Clinical Prevention Research Branch, PSP/DAIDS/NIAID/NIH, Bethesda, MD, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grant</LastName><ForeName>Robert M</ForeName><Initials>RM</Initials><AffiliationInfo><Affiliation>Gladstone Institutes, San Francisco AIDS Foundation, University of California, San Francisco, CA, USA.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>AIDS Behav</MedlineTA><NlmUniqueID>9712133</NlmUniqueID><ISSNLinking>1090-7165</ISSNLinking></MedlineJournalInfo><CommentsCorrectionsList><CommentsCorrections RefType="Cites"><RefSource>BMJ. 1995 Jul 15;311(6998):182-4</RefSource><PMID 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RefType="Cites"><RefSource>Am Psychol. 2013 May-Jun;68(4):225-36</RefSource><PMID Version="1">23688090</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>PLoS One. 2014 Feb 21;9(2):e89118</RefSource><PMID Version="1">24586534</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Health Policy. 2006 Apr;76(2):156-68</RefSource><PMID Version="1">16006004</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>AIDS Behav. 2012 Jul;16(5):1243-59</RefSource><PMID Version="1">22460228</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Prog Behav Modif. 1992;28:183-218</RefSource><PMID Version="1">1620663</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>BMC Med. 2014 Aug 21;12:142</RefSource><PMID Version="1">25145556</PMID></CommentsCorrections><CommentsCorrections RefType="Cites"><RefSource>Curr Opin HIV AIDS. 2012 Nov;7(6):498-504</RefSource><PMID 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