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

doi:10.1007/s10461-020-02808-2

Randomized Controlled Trial

. 2020 Sep;24(9):2520-2531.

doi: 10.1007/s10461-020-02808-2.

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

Elizabeth E Tolley¹, Sahar Z Zangeneh², Gordon Chau², Joe Eron³, Beatriz Grinsztejn⁴, Hilton Humphries⁵, Albert Liu⁶, Marc Siegel⁷, Maseko Bertha⁸, Ravindre Panchia⁹, Sue Li², Leslie Cottle², Alex Rinehart¹⁰, David Margolis¹⁰, Andrea Jennings¹¹, Marybeth McCauley¹², Raphael J Landovitz¹³

Affiliations

¹ Behavioral, Epidemiological & Behavioral Sciences, FHI 360, 359 Blackwell Street, Durham, NC, 27701, USA. btolley@fhi360.org.
² Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
³ University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁴ Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
⁵ Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.
⁶ Bridge HIV, Population Health Division, San Francisco Department of Public Health, San Francisco, CA, USA.
⁷ School of Medicine and Health Sciences, George Washington University, Washington, DC, USA.
⁸ UNC Project-Malawi, Lilongwe, Malawi.
⁹ Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa.
¹⁰ ViiV Healthcare, Durham, NC, USA.
¹¹ Science Facilitation, FHI 360, Durham, NC, USA.
¹² Science Facilitation, FHI 360, Washington, DC, USA.
¹³ UCLA Center for Clinical AIDS Research & Education, Los Angeles, CA, USA.

PMID: 32052214
PMCID: PMC7423859
DOI: 10.1007/s10461-020-02808-2

Free PMC article

Randomized Controlled Trial

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

Elizabeth E Tolley et al. AIDS Behav. 2020 Sep.

Free PMC article

. 2020 Sep;24(9):2520-2531.

doi: 10.1007/s10461-020-02808-2.

Authors

Affiliations

¹ Behavioral, Epidemiological & Behavioral Sciences, FHI 360, 359 Blackwell Street, Durham, NC, 27701, USA. btolley@fhi360.org.
² Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
³ University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
⁴ Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.
⁵ Centre for the AIDS Programme of Research in South Africa, University of KwaZulu-Natal, Durban, South Africa.
⁶ Bridge HIV, Population Health Division, San Francisco Department of Public Health, San Francisco, CA, USA.
⁷ School of Medicine and Health Sciences, George Washington University, Washington, DC, USA.
⁸ UNC Project-Malawi, Lilongwe, Malawi.
⁹ Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa.
¹⁰ ViiV Healthcare, Durham, NC, USA.
¹¹ Science Facilitation, FHI 360, Durham, NC, USA.
¹² Science Facilitation, FHI 360, Washington, DC, USA.
¹³ UCLA Center for Clinical AIDS Research & Education, Los Angeles, CA, USA.

PMID: 32052214
PMCID: PMC7423859
DOI: 10.1007/s10461-020-02808-2

Abstract

Long-acting injectable PrEP could offer an alternative to daily oral PrEP, improve adherence and protection, if found acceptable, safe and effective. HPTN 077 evaluated injectable cabotegravir safety, tolerability and pharmacokinetics among HIV-uninfected males and females in sequentially-enrolled cohorts of two dosing strategies. We compared acceptability of product attributes, prevention preferences and future interest in injectable PrEP (FIIP) by region, sex-at-birth, arm and cohort and used multivariable analysis to identify FIIP determinants. Baseline injectable PrEP preferences were higher in non-U.S. sites and increased in both regions over time. In multivariable models, FIIP was most strongly associated with acceptability of product attributes, was higher in non-U.S. sites and more altruistic participants. Treatment arm and report of pain were not associated with FIIP. Injectable acceptability was highest in non-U.S. sites. Preferences for injectable versus other PrEP methods were higher among U.S. males than females, but higher among males and females in non-U.S. settings.

Keywords: Acceptability; Clinical trial; Females; HIV prevention; Injectable; Males; PrEP.

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Figures

**Fig. 1**
Acceptability of product attributes and physical experiences at week 6, by region and cohort 1

**Fig. 2**
Acceptability of product attributes and physical experiences at week 6, by region and cohort 2

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References

1. World Health Organization HIV/AIDS. 2018;19:2018.
1. UNAIDS . UNAIDS Data 2019. Switzerland: UNAIDS; 2019.
1. UN Women. Facts and figures: HIV and AIDS. UN Women; 2018.
1. Centers for Disease Control and Prevention . Estimated HIV incidence and prevalence in the United States, 2010–2016. Atlanta: CDC; 2019.
1. Baeten JM, Donnell D, Ndase P, Mugo NR, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399–410. doi: 10.1056/NEJMoa1108524. - DOI - PMC - PubMed

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[1] World Health Organization HIV/AIDS. 2018;19:2018.

[2] World Health Organization HIV/AIDS. 2018;19:2018.

[3] UNAIDS . UNAIDS Data 2019. Switzerland: UNAIDS; 2019.

[4] UNAIDS . UNAIDS Data 2019. Switzerland: UNAIDS; 2019.

[5] UN Women. Facts and figures: HIV and AIDS. UN Women; 2018.

[6] UN Women. Facts and figures: HIV and AIDS. UN Women; 2018.

[7] Centers for Disease Control and Prevention . Estimated HIV incidence and prevalence in the United States, 2010–2016. Atlanta: CDC; 2019.

[8] Centers for Disease Control and Prevention . Estimated HIV incidence and prevalence in the United States, 2010–2016. Atlanta: CDC; 2019.

[9] Baeten JM, Donnell D, Ndase P, Mugo NR, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399–410. doi: 10.1056/NEJMoa1108524. - DOI - PMC - PubMed

[10] Baeten JM, Donnell D, Ndase P, Mugo NR, et al. Antiretroviral prophylaxis for HIV prevention in heterosexual men and women. N Engl J Med. 2012;367(5):399–410. doi: 10.1056/NEJMoa1108524. - DOI - PMC - PubMed

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

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

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