Acceptability of Long-Acting Injectable Cabotegravir (CAB LA) in HIV-Uninfected Individuals: HPTN 077

Tolley, Elizabeth E.; Zangeneh, Sahar Z.; Chau, Gordon; Eron, Joe; Grinsztejn, Beatriz; Humphries, Hilton; Liu, Albert; Siegel, Marc; Maseko, Bertha; Panchia, Ravindre; Li, Sue; Cottle, Leslie; Rinehart, Alex; Margolis, David; Jennings, Andrea; McCauley, Marybeth; Landovitz, Raphael J.

doi:10.1007/s10461-020-02808-2

Cited by 57 publications

(46 citation statements)

References 34 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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

Self Cite

View full text Add to dashboard Cite

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.

show abstract

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

Self Cite

View full text Add to dashboard Cite

show abstract

“…As effective PrEP approaches (eg, pills, vaginal rings, 22 , 23 injectables, 24 etc) become licensed and scaled up and are increasingly accessible and acceptable, these biomedical tools will become part of the standard of prevention at the community level and in clinical trials. For trials, it could become increasingly challenging to convincingly show effectiveness of new biomedical HIV prevention technologies (eg, new PrEP drugs and HIV vaccines), if the expected rate of HIV infections will be small because of effective prevention.…”

Section: Discussionmentioning

confidence: 99%

Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study

et al. 2021

View full text Add to dashboard Cite

Background As oral pre-exposure prophylaxis (PrEP) becomes the standard of prevention globally, its potential effect on HIV incidence in clinical trials of new prevention interventions is unknown, particularly for trials among women. In a trial measuring HIV incidence in African women, oral PrEP was incorporated into the standard of prevention in the trial's last year. We assessed the effect of on-site access to PrEP on HIV incidence in this natural experiment.Methods We did a nested interrupted time-series study using data from the ECHO trial. At 12 sites in four countries (Eswatini, Kenya, South Africa, and Zambia), women (aged 16-35 years) were randomly assigned to receive one of three contraceptives between Dec 14, 2015, and Sept 12, 2017, and followed up quarterly for up to 18 months to determine the effect of contraceptive method on HIV acquisition. Women were eligible if they wanted long-acting contraception, were medically qualified to receive study contraceptives, and had not used any of the study contraceptives in the past 6 months. The present analyses are limited to nine South African sites where on-site access to oral PrEP was implemented between March 13 and June 12, 2018. Using an interrupted time-series design, we compared HIV incidence before versus after PrEP access, limited to quarterly study visits at which on-site PrEP access was available to at least some participants and, in a sensitivity analysis, to the 180 days before and after access. The outcome was incident HIV infection, detected using two rapid HIV tests done in parallel for each participant at every scheduled follow-up visit. This study is registered on ClinicalTrials.gov, NCT02550067. Findings 2124 women were followed up after on-site PrEP access began, of whom 543 (26%) reported PrEP use. A total of 12 HIV seroconversions were observed in 556 person-years (incidence 2•16%) after on-site PrEP access, compared with 133 HIV seroconversions in 2860 person-years (4•65%) before PrEP access (adjusted incidence rate ratio [IRR] 0•45, 95% CI 0•25-0•82, p=0•0085). Similar results were also observed when limiting the analysis to 180 days before versus after PrEP access. A total of 46 HIV seroconversions were observed in 919 person-years within 180 days before PrEP access, compared with 11 seroconversions in 481 person-years in the 180 days following PrEP access (incidence 5•00 vs 2•29 per 100 person-years; IRR 0•43, 95% CI 0•22-0•88, p=0•012). Interpretation On-site access to PrEP as part of standard of prevention in a clinical trial among women in South Africa was associated with halving HIV incidence, when approximately a quarter of women started PrEP. Providing access to on-site PrEP could decrease incidence in HIV prevention trials. These data are also among the first to show in any setting that access to PrEP is associated with decreased HIV acquisition among South African women.

show abstract

“…Previous studies, mostly done in adult women have suggested that delivery in a long-lasting injection would be a good target for drug development [15][16][17][18]. However, given the distinct developmental, physical and social differences between adult women and female adolescents [19], it is essential to explore how the mode of delivery of an HIV prevention option impacts acceptability and use in the adolescent population.…”

mentioning

confidence: 99%

An open‐label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose)

Gill

Happel

Pidwell

et al. 2020

J. Intern. AIDS Soc.

Self Cite

View full text Add to dashboard Cite

Introduction: Young women in Southern Africa have extremely high HIV incidence rates necessitating the availability of female-controlled prevention methods. Understanding adolescent preference for seeking contraception would improve our understanding of acceptability, feasibility and adherence to similar modes of delivery for HIV prevention. Methods: UChoose was an open-label randomized crossover study over 32 weeks which aimed to evaluate the acceptability and preference for contraceptive options in healthy, HIV-uninfected, female adolescents aged 15 to 19 years, as a proxy for similar HIV prevention methods. Participants were assigned to a contraceptive method for a period of 16 weeks in the form of a bimonthly injectable contraceptive, monthly vaginal Nuvaring â or daily combined oral contraceptive (COC) and then asked to state their preference. At 16 weeks, participants crossed over to another contraceptive method, to ensure that all participants tried the Nuvaring â (least familiar modality) and additionally, either the injection or COC. Primary outcomes were contraceptive acceptability and preference. At the end of the 32 weeks they were also asked to imagine their preference for an HIV prevention modality. Secondary endpoints included changes in sexual behaviour, contraceptive adherence and preference for biomedical and behavioural HIV prevention methods. Results: Of the 180 participants screened, 130 were enrolled and randomized to the Nuvaring â (n = 45), injection (n = 45) or COC (n = 40). Significantly more Nuvaring â users (24/116; 20.7%) requested to change to another contraceptive option compared to injection (1/73; 1.4% p = 0.0002) and COC users (4/49; 8% p = 0.074). Of those that remained on the Nuvaring â , adherence was significantly higher than to COC (p < 0.0001). Significantly more injection users (77/80; 96.3%) thought this delivery mode was convenient to use compared to Nuvaring â (74/89; 83.1%; p = 0.0409) or COC (38/50; 76.0%; p = 0.0034). Overall, the preferred contraceptive choice was injection, followed by the ring and lastly the pill. Conclusions: Adherence to daily COC was difficult for adolescents in this cohort and the least favoured potential HIV prevention option. While some preferred vaginal ring use, these data suggest that long-acting injectables would be the preferred prevention method for adolescent girls and young women. This study highlights the need for additional options for HIV prevention in youth.

show abstract

Acceptability of Long-Acting Injectable Cabotegravir (CAB LA) in HIV-Uninfected Individuals: HPTN 077

Cited by 57 publications

References 34 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)

Incorporating oral PrEP into standard prevention services for South African women: a nested interrupted time-series study

An open‐label, randomized crossover study to evaluate the acceptability and preference for contraceptive options in female adolescents, 15 to 19 years of age in Cape Town, as a proxy for HIV prevention methods (UChoose)

Contact Info

Product

Resources

About