Browsing by Author "MacQueen, Kathleen M."

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Adherence in the CAPRISA 004 tenofovir gel microbicide trial.
(Springer., 2014) Mansoor, Leila Essop.; Abdool Karim, Quarraisha.; Yende-Zuma, Fortunate Nonhlanhla.; MacQueen, Kathleen M.; Baxter, Cheryl.; Madlala, Bernadette T.; Grobler, Anneke.; Abdool Karim, Salim Safurdeen.
High adherence is key to microbicide effectiveness. Here we provide a description of adherence interventions and the adherence rates achieved in the CAPRISA 004 Tenofovir Gel Trial. Adherence support for the before-and-after dosing strategy (BAT 24) was provided at enrolment and at each monthly study visit. This initially comprised individual counselling and was replaced midway by a structured theory-based adherence support program (ASP) based on motivational interviewing. The 889 women were followed for an average of 18 months and attended a total of 17031 monthly visits. On average women reported 5 sex acts and returned 5.9 empty applicators per month. The adherence rate based on applicator count in relation to all reported sex acts was 72.2% compared to the 82.0% self-reported adherence during the last sex act. Adherence support activities, which achieve levels of adherence similar to or better than those achieved by the CAPRISA 004 ASP, will be critical to the success of future microbicide trials.
Adolescents and HIV clinical trials: ethics, culture, and context.
(Elsevier., 2007) MacQueen, Kathleen M.; Abdool Karim, Quarraisha.
One quarter of HIV infections globally occur among young people 15-24 years of age and more than half of all new infections are to people younger than 25 years. Clearly, there is a need to identify and implement effective HIV prevention strategies among at-risk teens. Some of the most effective options for slowing the epidemic are biomedical and several promising methods are in development, including microbicides, vaccines, and pre-exposure prophylaxis (PREP) or the daily use of antiretrovirals to prevent the acquisition of HIV. There is widespread reluctance to enroll minors in such biomedical prevention trials due to concerns about vulnerability related to physical maturity, experiential maturity, and diminished autonomy as well as legal and social challenges that vary across and within nations. However, excluding minors from trials misses an important opportunity to evaluate the effectiveness, acceptability, and safety of innovative interventions under the best conditions for identifying and resolving potential problems. The challenges of including minors in HIV prevention trials are highlighted via the example of one rural South African community that has been particularly devastated by the HIV epidemic.
Assessing adherence in the CAPRISA 004 tenofovir gel HIV prevention trial: results of a nested case–control study.
(Springer., 2014) MacQueen, Kathleen M.; Weaver, Mark A.; van Loggerenberg, Francois.; Succop, Stacey M.; Majola, Nelisile.; Taylor, Douglas.; Abdool Karim, Quarraisha.; Abdool Karim, Salim Safurdeen.
Abstract available in pdf.
Evaluating community engagement in global health research: the need for metrics.
(BioMed Central., 2015) MacQueen, Kathleen M.; Bhan, Anant.; Fröhlich, Janet Ann.; Holzer, Jessica.; Sugarman, Jeremy.
Abstract available in pdf.
Impact of an adherence intervention on the effectiveness of tenofovir gel in the CAPRISA 004 trial.
(Springer., 2014) Mansoor, Leila Essop.; Abdool Karim, Quarraisha.; Werner, Lise.; Madlala, Bernadette T.; Ngcobo, Nelisiwe.; Cornman, Deborah H.; Amico, Kathy Rivet.; Fisher, Jeffrey D.; Fisher, William A.; MacQueen, Kathleen M.; Abdool Karim, Salim Safurdeen.
Abstract not available in pdf.
Microbicide clinical trial adherence: insights for introduction.
(BioMed Central., 2012) Woodsong, Cynthia.; MacQueen, Kathleen M.; Amico, Kathy Rivet.; Friedland, Barbara A.; Gafos, Mitzy.; Mansoor, Leila Essop.; Tolley, Elizabeth E.; McCormack, Sheena.
After two decades of microbicide clinical trials it remains uncertain if vaginally- delivered products will be clearly shown to reduce the risk of HIV infection in women and girls. Furthermore, a microbicide product with demonstrated clinical efficacy must be used correctly and consistently if it is to prevent infection. Information on adherence that can be gleaned from microbicide trials is relevant for future microbicide safety and efficacy trials, pre-licensure implementation trials, Phase IV post-marketing research, and microbicide introduction and delivery. Drawing primarily from data and experience that has emerged from the large-scale microbicide efficacy trials completed to-date, the paper identifies six broad areas of adherence lessons learned: (1) Adherence measurement in clinical trials, (2) Comprehension of use instructions/Instructions for use, (3) Unknown efficacy and its effect on adherence/Messages regarding effectiveness, (4) Partner influence on use, (5) Retention and continuation and (6) Generalizability of trial participants’ adherence behavior. Each is discussed, with examples provided from microbicide trials. For each of these adherence topics, recommendations are provided for using trial findings to prepare for future microbicide safety and efficacy trials, Phase IV post-marketing research, and microbicide introduction and delivery programs.
Secrecy, empowerment and protection : positioning PrEP in KwaZulu-Natal, South Africa.
(Taylor & Francis., 2017) Govender, Eliza Melissa.; Mansoor, Leila Essop.; MacQueen, Kathleen M.; Abdool Karim, Quarraisha.
Abstract available in pdf.
Social context of adherence in an open-label 1% tenofovir gel trial : gender dynamics and disclosure in KwaZulu-Natal, South Africa.
(Springer., 2016) MacQueen, Kathleen M.; Dlamini, Sarah Alexandra.; Perry, Brian.; Okumu, Eunice.; Sortijas, Steve.; Singh, Chitra.; Pillay, Diantha.; Majors, Alesha.; Jerome, Sonja.; Watson, Sharon.; Abdool Karim, Salim Safurdeen.; Abdool Karim, Quarraisha.; Mansoor, Leila Essop.
Abstract available in PDF file.
Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial.
(Succop, S.M., MacQueen, K.M., van Loggerenberg, F., Majola, N., Abdool Karim, Q. and Abdool Karim, S.S. 2014. Trial participation disclosure and gel use behavior in the CAPRISA 004 tenofovir gel trial. AIDS care 26(12), 1521-1525., 2014) Succop, Stacey M.; MacQueen, Kathleen M.; van Loggerenberg, Francois.; Majola, Nelisile.; Abdool Karim, Quarraisha.; Abdool Karim, Salim Safurdeen.
Abstract available in pdf.