Expanding the Menu of HIV Prevention Options: A Qualitative Study of Experiences with Long-Acting Injectable Cabotegravir as PrEP in the Context of a Phase II Trial in the United States

Kerrigan, Deanna; Mantsios, Andrea; Grant, Robert M.; Markowitz, Marty; Defechereux, Patricia; Mar, Melissa La; Beckham, S. Wilson; Hammond, Paige; Margolis, David; Murray, Miranda

doi:10.1007/s10461-017-2017-x

Cited by 49 publications

(49 citation statements)

References 44 publications

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“…It is noteworthy that participants' attitudes towards product attributes, including receiving two injectionsone in each buttock every two-months, was a stronger predictor of future interest in use than were their experiences with pain and other side effects. These findings are similar to acceptability data recently presented from a phase 2 trial of Cabotegravir LA (CAB LA) injectable (HPTN 077) [30] and a qualitative sub-study of ECLAIR, a phase 2 trial of CAB LA in MSM, which found overall high levels of acceptability, despite frequent but variable experiences of pain [31]. As additional long-acting PrEP modalities like implants and antibodies move through clinical trial research [32], there is an opportunity to further assess how participants understand and experience product features and the relative trade-offs they would consider in choosing and using a PrEP product.…”

Section: Discussionsupporting

confidence: 87%

Acceptability of a long‐acting injectable HIV prevention product among US and African women: findings from a phase 2 clinical Trial (HPTN 076)

Tolley

Zangeneh

et al. 2019

J Intern AIDS Soc

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IntroductionHigh HIV incidence and low adherence to daily oral PrEP among women underscore the need for more acceptable and easier to use HIV prevention products. Global demand for injectable contraception suggests that new, long‐acting, injectable formulations could meet this need. We examine acceptability of a long‐acting injectable PrEP among HIV‐uninfected women in Zimbabwe, South Africa and two United States phase 2 trial sites.MethodsQuantitative surveys were administered at the first, fourth and sixth injection visits. Focus group discussions (FGD) were conducted after the sixth injection visit. We compared the acceptability of injectable product attributes, prevention preferences and future interest in injectable PrEP by site and arm and ran longitudinal ordinal logistic regression models to identify determinants of future interest in injectable PrEP.ResultsBetween April 2015 and February 2017, the trial enrolled 136 (100 African, 36 US) women with a median age of 31 years. Most participants (>75%) rated injectable attributes as very acceptable. While few reported rash or other side effects, 56% to 67% reported injection pain, with nonsignificant differences over time and between arms. During FGDs, participants described initial fear of the injectable and variable experiences with pain. Most US and African participants preferred injectable PrEP to daily oral pills (56% to 96% vs. 4% to 25%). Future interest in using injectable PrEP was associated with acceptability of product attributes and was higher in African than US sites. In FGDs, participants described multiple reasons for trial participation, including a combination of monetary, health‐related and altruistic motivations. While associated with future interest in use in univariate models, neither altruistic nor personal motivations remained significant in the multivariate model.ConclusionsThis study found that long‐acting injectable PrEP is acceptable among African and US women experiencing product use. Acceptability of product attributes better predicted future interest in injectable use than experience of pain. This is reassuring as a single‐dose regimen of a different product has advanced to phase 3 trials. Finally, the study suggests that future demand for an injectable PrEP by women may be greater in African than US settings, where the risk of HIV is highest.

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Section: Discussionsupporting

confidence: 87%

Acceptability of a long‐acting injectable HIV prevention product among US and African women: findings from a phase 2 clinical Trial (HPTN 076)

Tolley

Zangeneh

et al. 2019

J Intern AIDS Soc

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“…We identified that a fear of needles may impede LAI use in some, but these fears were assuaged through having a health provider administer the injection, thinking of needles as a blood draw that they are familiar with, or remembering that the injection will provide protection from HIV. Educational programing that addresses these reported concerns with injectable PrEP use and that incorporates these case scenarios (i.e., injectable options for birth control and diabetes treatment) is crucial for increasing PrEP uptake by community members during early phases of the PrEP implementation process with these new products [32, 52]. Furthermore, injectable PrEP could be administered by a pharmacist or other health provider within pharmacy-based clinics, an emerging delivery model in the US, to address some of these reported barriers [53, 54].…”

Section: Discussionmentioning

confidence: 99%

Pre-exposure prophylaxis for HIV prevention preferences among young adult African American men who have sex with men

et al. 2018

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Pre-exposure prophylaxis (PrEP) is effective in preventing HIV infections among men who have sex with men (MSM). PrEP uptake and adherence remain low and product preferences are unknown, especially among young African American MSM who are most at-risk. We conducted 26 qualitative interviews from 2014–2016 among young adult HIV-negative African American MSM regarding PrEP product preferences in Missouri. While the pill and injectable were most liked of all modalities, about a quarter preferred rectal products or patches. Most participants preferred a long-acting injectable (LAI) to daily oral pills due to better medication adherence and a dislike for taking pills. Many participants preferred daily oral pills to on-demand oral PrEP due to the inability to predict sex and the perception that insufficient time or medication would not achieve HIV protection with on-demand. A fear of needles and the perception that there would not be therapeutic levels for a long duration were concerns with injectable PrEP. Study findings highlight the need for a range of prevention options for African American MSM and can inform PrEP product development as well as dissemination and implementation efforts.

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“…The qualitative interviews demonstrated the importance of the convenience of an LA injectable as providing "peace of mind," an overall sense that the participants were interested in continuing treatment even with minor injection soreness, noting a perceived advantage of not "having to remember to adhere to a daily oral regimen." 18 All participants reported being satisfied with cabotegravir LA injection for PrEP, would recommend it as an alternative treatment, and would be interested in continuing when the option becomes commercially available. Disadvantages identified included the needles being relatively long and the location of the injection site was uncomfortable.…”

Section: Discussionmentioning

confidence: 99%

“…In a separate substudy of participants in ECLAIR, qualitative interviews were conducted with 26 volunteers at two sites (New York, n ¼ 15; San Francisco, n ¼ 11) to determine participants' experience with cabotegravir LA. 18 Oral consent was obtained from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board onsite.…”

Section: Pro Assessmentsmentioning

confidence: 99%

Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial

Murray

Markowitz

Frank

et al. 2018

HIV Clinical Trials

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Background: Cabotegravir (GSK1265744) is an integrase strand transfer inhibitor in development as a longacting (LA) intramuscular injectable suspension for HIV-1 pre-exposure prophylaxis (PrEP). Objective: We report participant outcomes from the phase IIa ECLAIR study related to tolerability, acceptability, and satisfaction of cabotegravir LA. Methods: The ECLAIR study (ClinicalTrials.gov identifier, NCT02076178) was a randomized, placebo-controlled study in healthy men not at high risk of acquiring HIV-1. Participants were randomized (5:1) to oncedaily oral cabotegravir 30 mg or placebo tablets for 4 weeks, followed by gluteal intramuscular injections of cabotegravir LA 800 mg or saline placebo every 12 weeks. The primary objective was to evaluate the safety of cabotegravir LA over three injection cycles (to Week 41). Secondary objectives assessed the tolerability, satisfaction, and acceptability of cabotegravir LA. Results: Among 115 participants who received injections in the cabotegravir (n ¼ 94) and placebo (n ¼ 21) groups, 93% (n ¼ 87) and 95% (n ¼ 20) completed the injection phase, respectively. Injection intolerability led to withdrawal in 4 participants (4%) receiving cabotegravir LA. The most frequently reported Grade 2 adverse event was injection-site pain. Most participants (74% [n ¼ 67]) receiving consecutive injections favored cabotegravir LA vs oral cabotegravir. Most participants were satisfied with cabotegravir LA (75% [n ¼ 64]), were willing to continue (79% [n ¼ 68]), and would recommend (87% [n ¼ 75]) the therapy. Conclusions: While Grade 2 injection-site pain was common, most participants reported overall satisfaction with and preference for cabotegravir LA, with few discontinuations due to injection intolerance. These findings support investigation of cabotegravir LA as an alternative to daily oral PrEP regimens.

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Expanding the Menu of HIV Prevention Options: A Qualitative Study of Experiences with Long-Acting Injectable Cabotegravir as PrEP in the Context of a Phase II Trial in the United States

Cited by 49 publications

References 44 publications

Acceptability of a long‐acting injectable HIV prevention product among US and African women: findings from a phase 2 clinical Trial (HPTN 076)

Acceptability of a long‐acting injectable HIV prevention product among US and African women: findings from a phase 2 clinical Trial (HPTN 076)

Pre-exposure prophylaxis for HIV prevention preferences among young adult African American men who have sex with men

Satisfaction and acceptability of cabotegravir long-acting injectable suspension for prevention of HIV: Patient perspectives from the ECLAIR trial

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