The preventive misconception: experiences from CAPRISA 004.
Overestimating personal protection afforded by participation in a preventive trial, e.g. harboring a "preventive misconception" (PM), raises theoretical ethical concerns about the adequacy of the informed consent process, behavioral disinhibition, and adherence to prevention interventions. Data from the CAPRISA 004 1 % tenofovir gel trial were utilized to empirically evaluate these concerns. We found it necessary to re-think the current definition of PM during evaluation to distinguish between true misconception and reasonable inferences of protection based on increased access to evidence-based prevention interventions and/or clinical care. There was a significant association between PM and decreased condom use (p < 0.0001) and between PM and likelihood to present with an STI symptom (p = 0.023). There was, however, limited evidence in support of PM representing a lack of meaningful informed consent, or to suggest that it impacts adherence. Moreover, considering current insufficiencies in female-initiated HIV prevention interventions, PM is perhaps of limited concern in microbicide trials.
Centre for the AIDS Programme of Research in South Africa (CAPRISA), Nelson R Mandela School of Medicine, University of KwaZulu-Natal, Durban, South Africa.
Rachael C
RC
Dellar
Quarraisha
Q
Abdool Karim
Leila E
LE
Mansoor
Anneke
A
Grobler
Hilton
H
Humphries
Lise
L
Werner
Fanelesibonge
F
Ntombela
Londiwe
L
Luthuli
Salim S
SS
Abdool Karim
D000225:Adenine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000293:Adolescent; D000328:Adult; D019380:Anti-HIV Agents / Q000008:administration & dosage*; D000891:Anti-Infective Agents, Local; D005260:Female; D005782:Gels; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D007258:Informed Consent; D055118:Medication Adherence; D009042:Motivation; D063065:Organophosphonates / Q000008:administration & dosage*; D010549:Personal Satisfaction; D013019:South Africa; D000068698:Tenofovir; D055815:Young Adult
D019380:Anti-HIV Agents; D000891:Anti-Infective Agents, Local; D005782:Gels; D063065:Organophosphonates; D000068698:Tenofovir; D000225:Adenine