Does the Ring Work? Perceptions and Understanding of the Efficacy of a Dapivirine Vaginal Ring for HIV Prevention Amongst Women in a Placebo-Controlled Trial

2021 ◽  
Author(s):  
Juliane Etima ◽  
Ariana W. K. Katz ◽  
Zoe Duby ◽  
Morgan Garcia ◽  
Thesla Palanee-Phillips ◽  
...  
2018 ◽  
Author(s):  
Krystal Madkins ◽  
David Moskowitz ◽  
Kevin Moran ◽  
Trey Dellucci ◽  
Brian Mustanski

BACKGROUND Since 2010, HIV diagnoses among men who have sex with men (MSM) have remained stably high while decreasing for heterosexual men and women. The burden of infection has disproportionately impacted younger MSM of color relative to other populations. Despite the increased risk, there are few HIV prevention programs targeted to diverse and young MSM. The Keep It Up! (KIU!) online intervention was created to address the HIV prevention needs of this population. OBJECTIVE The objective of this study was to examine the acceptability and engagement of KIU!, and explore any differences by demographics, within the context of a randomized controlled trial (RCT). METHODS Between May 2013 and December 2015, 445 participants were randomized into the intervention arm of the KIU! RCT. Data were taken from the baseline assessment, KIU! 2.0 intervention modules, and immediate post-test assessments of intervention acceptability and engagement. Outcomes of interests were qualitative and quantitative measures of intervention acceptability and engagement as well as process measures (i.e., star ratings of intervention content and paradata on time spent in intervention). RESULTS Participants were an average of 24 years old, 62.9% (280/445) identified as a racial or ethnic minority, 86.5% (385/445) identified as gay, and 84.3% (375/445) reported having at least some college education. Most participants rated the intervention content highly (4 out of 5 stars) and gave the intervention an average acceptability score of 3.5 out of 4. Compared to White participants, Black participants found the intervention more useful (p = .03), engaging (p < .001), and acceptable (p = .001); Latino participants found the intervention more engaging (p = .03); and “other” non-White participants found the intervention more engaging (p = .008) and acceptable (p = .02). Participants with high school or less education found the intervention more useful, engaging, and acceptable, and were more likely to give intervention content a five star rating than college educated participants (p-values = .047, <.001, .002, .01 respectively) or those with graduate degrees (p-values = .04, .001, < .001, .004 respectively). White participants showed the most variation between education levels and reporting positive attitudes towards the intervention. Among Black participants, graduate degree-earning participants spent significantly more time on the intervention than high-school or less educated participants (p = .02). CONCLUSIONS Overall, participants gave the intervention high acceptability and engagement ratings; but it was most acceptable and engaging to participants who were younger, identified as racial and ethnic minorities, had less education, and lived in the South. As these are all groups with greater burden of HIV infection, the KIU! intervention is promising as a primary HIV prevention tool. Future implementations of KIU! are needed to assess its acceptability outside of the highly controlled environment of an RCT. CLINICALTRIAL RCT# NCT01836445


2011 ◽  
Vol 16 (2) ◽  
pp. 469-479 ◽  
Author(s):  
Keith J. Horvath ◽  
Kate Nygaard ◽  
Gene P. Danilenko ◽  
Sinan Goknur ◽  
J. Michael Oakes ◽  
...  

PLoS ONE ◽  
2020 ◽  
Vol 15 (12) ◽  
pp. e0242881
Author(s):  
Elizabeth E. Tolley ◽  
Seth Zissette ◽  
Andres Martinez ◽  
Thesla Palanee-Phillips ◽  
Florence Mathebula ◽  
...  

In HIV prevention trials, male partners have influenced women’s ability to adhere to investigational products, including antiretroviral (ARV) containing vaginal rings. Validated scales can be useful tools to systematically measure complex constructs, such as those related to male partner engagement. Although multiple scales exist to assess physical, psychological and sexual violence within intimate relationships, fewer scales focus on supportive behaviors within these relationships. Our intervention involved development of a Healthy Relationship Assessment Tool (HEART) that assessed both positive and negative aspects of male partner involvement in women’s HIV prevention. We identified and refined 127 potential items, representing intimate partner violence, agency and social support. A structured survey, including potential items and other sociodemographic and behavioral variables was administered to former microbicide trial and non-trial participants. We conducted an exploratory factor analysis (EFA) to identify a reduced set of constructs and items to screen women who might experience social harms or benefits from vaginal ring use. We examined associations between constructs and with other survey variables to assess content and construct validity. In a subset of 10 women who participated in the survey and qualitative interviews, we used qualitative data to predict survey scores. We retained five constructs with theoretical relevance and good-to-strong reliability for the tool, including: Traditional Values; Partner Support; Partner Abuse & Control; Partner Resistance to HIV Prevention; and HIV Prevention Readiness. Predicted associations between HEART constructs, and correspondence between participants’ qualitative data and HEART scores were generally correct, while those between constructs and other sociodemographic variables were more mixed. Initial validation of the HEART tool was promising. The tool will be used during the CHARISMA pilot study at the Johannesburg MTN 025/HOPE site and validated as part of a randomized controlled trial of CHARISMA within a PrEP demonstration project. Beyond clinical trial settings, HEART could assist PrEP or antiretroviral treatment (ART) providers with an easy-to-administer tool to identify risk and tailor risk reduction, empowerment and adherence counseling for microbicides, PrEP or ART related services.


2020 ◽  
Vol 10 (5) ◽  
pp. 1211-1220
Author(s):  
Kimberly M Nelson ◽  
Nicholas S Perry ◽  
Keith J Horvath ◽  
Laramie R Smith

Abstract The use of mobile health (mHealth) technologies addressing HIV disparities among gay, bisexual, and other men who have sex with men (GBMSM) has increased. A systematic review of mHealth interventions for HIV prevention and treatment among GBMSM was conducted to summarize the current evidence and provide recommendations for future research. PRISMA guidelines were followed (PROSPERO ID: 148452). Studies identified via PubMed, PsychInfo, or Embase were included that (i) were in English, (ii) were published in a peer-reviewed journal prior to July 1, 2019, (iii) presented primary results, (iv) included only GBMSM, and (v) reported the results of an mHealth intervention (e.g., text message, phone/mobile application [app]) to improve HIV prevention or treatment outcomes. Of 1,636 identified abstracts, 16 published studies met inclusion criteria. Eleven studies were conducted in the United States. One study was a fully powered randomized controlled trial (RCT), seven were single-arm pilots with pre–post assessments, four were pilot RCTs, and four tested public health campaigns with post-assessments. Seven developed study-specific apps, five used text messaging, and four used existing social networking apps. Most (81%) targeted prevention outcomes. Nine cited a specific behavioral theory. All studies found that a mHealth approach was feasible and acceptable. All interventions provided evidence of preliminary efficacy or promising trends on primary outcomes. Although mHealth interventions for HIV prevention and treatment appear feasible and acceptable, most published studies are small pilot trials. Additional research assessing the efficacy and mechanisms of mHealth interventions is needed.


2012 ◽  
Vol 16 (7) ◽  
pp. 1775-1786 ◽  
Author(s):  
A. van der Straten ◽  
E. T. Montgomery ◽  
H. Cheng ◽  
L. Wegner ◽  
G. Masenga ◽  
...  

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