Quantitative and Qualitative Perspectives of Participants Who Received Long-Acting Injectable Cabotegravir-Rilpivirine at Home or in Clinic

Abstract

Injectable antiretroviral options for the treatment of HIV-1 infection have demonstrated the potential to reduce pill fatigue, improve medication adherence, increase patient satisfaction, and reduce stigma compared to oral antiretroviral therapy. In a recent non-randomized observational study, we previously examined safety and efficacy outcomes for participants who chose where to receive long-acting cabotegravir/rilpivirine over a 12-month period. This study demonstrated that at-home administration of long-acting cabotegravir/rilpivirine by a home health provider was comparably safe, effective, and associated with high satisfaction compared to in-clinic administration. To further understand the experience and impact of this intervention from the perspective of study participants, we analyzed quantitative end-of-intervention surveys and qualitative exit interviews offered to study participants after completion of the intervention. Using a grounded theory approach to analyze exit interviews, we conducted an iterative process of establishing codes, grouping the codes into key concepts, and organizing concepts into broader themes. We identified six broad themes related to the participant experience that involved (1) strengths of injectable therapy, (2) negatives of injectable therapy, (3) treatment setting preference, (4) reasons for preferring injectable therapy at home, (5) reasons for preferring injectable therapy in the clinic, and (6) general impressions related to injectable therapy. This work provides insight into patient perceptions and preferences regarding injectable HIV therapy, perspectives that will be important to consider for efforts designed to enhance accessibility of injectable HIV therapy and optimize the patient experience.

Introduction

Use of injectable antiretroviral therapy for treatment of HIV-1 infection, including long-acting injectable cabotegravir plus rilpivirine (LA CAB/RPV) administered every 1–2 months, has demonstrated beneficial capacity to reduce pill fatigue, improve medication adherence, heighten patient satisfaction, and reduce stigma compared to oral antiretroviral therapy. ^{1 –6} Prior studies of LA CAB/RPV identified strengths that included improved access to care and treatment adherence, ^{7 –11} as well as barriers, including potential limitations on access for individuals who may be unable or unwilling to present to a clinic for injections due to factors such as transportation or stigma concerns. ^7,12 To address these barriers, we recently conducted a non-randomized observational study that ex amined outcomes of participants who after receiving their initial LA CAB/RPV injection in the clinic, elected to receive subsequent injections at home or in the clinic; injections were administered every 4 weeks when the study was initiated and could be extended to every 8 weeks upon FDA approval for this frequency of administration. ¹³ This study demonstrated that at-home administration of LA CAB/RPV by a health care provider was comparably safe, effective, and associated with high satisfaction relative to in-clinic administration. ¹³ To further understand the impact of this intervention from the perspective of study participants, we conducted an in-depth analysis of participant responses from quantitative end-of-intervention surveys and qualitative exit interviews offered to each study participant following completion of the 12-month intervention.

Methods

Participants and recruitment

All 33 participants who enrolled in the non-randomized observational 12-month study, whose design and results have been previously reported, ¹³ were offered an opportunity to complete an end-of-intervention survey and exit interview. Twenty-six participants completed end-of-intervention quantitative surveys using REDCap, including 13 who primarily received injections in clinic and 13 who primarily received injections at home. Fourteen participants completed qualitative exit interviews, including five who primarily received injections in the clinic and nine who primarily received injections at home. One participant who completed an exit interview received treatment primarily in the clinic but switched to at-home administration near the end of the 12-month intervention.

Procedures

Select results from quantitative surveys offered at the end of the 12-month intervention of receiving LA CAB/RPV injections either at home or in clinic were previously reported. ¹³ Surveys were completed electronically by participants via sharing of a survey link, took approximately 15 min to complete, and inquired about how likely participants were to continue receiving LA CAB/RPV for treatment, opinions about LA CAB/RPV treatment, benefits and concerns about switching to injectable HIV treatment, ease of and time spent on injection visits, acceptance of at-home and in-clinic injections, access and preference for treatment settings, and privacy considerations of taking HIV medication.

The likelihood of continuing to receive therapy for HIV with injectable treatment was measured by one question on a 4-point Likert scale ranging from (1) very likely to (4) very unlikely. Opinions about LA CAB/RPV treatment were measured by four questions on a Likert scale from (1) completely disagree to (5) completely agree: “Treatment met my needs for treating HIV;” “Treatment is still appealing;” “I like the injection for treating my HIV;” and “The injection treatment was a good match for my life.” Benefits of injectable HIV treatment were captured with 11 questions measured dichotomously (yes/no) (e.g., “monthly injections were more convenient;” “I didn’t have to hide my HIV medications from others;” “I don’t worry about getting my refills from the pharmacy every month in time”). Potential concerns about injectable HIV treatment were measured dichotomously (yes/no) using 14 questions (e.g., “pain/soreness of the injection;” “finding parking at the clinic for monthly appointments;” “I had trouble remembering monthly appointments to get the injection.”).

Ease of receiving injections was measured via one question (“How easy was it for you to get to the clinic for monthly injections?”) ranging from (1) very easy to (4) very difficult. Time to receive treatment was assessed via one question (“How much time did you spend on average at the clinic for each monthly injection visit?”: 1–15 min, 16–30 min, 31–45 min, 46–60 min). Acceptability of injections was assessed with three questions (e.g., “how acceptable was it for you to come to the clinic monthly to get an injection?;” “if you elected monthly injection at home, was this option acceptable for you?”) ranging from (1) extremely acceptable to (5) not acceptable. Access was measured via one question, “Did you have trouble accessing injectable therapy through the insurance company that provides you with your HIV medication?” on a dichotomous scale (yes/no). Preference for treatment setting was measured through three questions about preferred treatment method (injections in the clinic; injections at home administered by health care provider; oral treatment), factors related to preference (i.e., convenience, privacy concerns, other), and preferred method for being reminded about visits (i.e., reminder phone calls, reminder text messages, reminder app on smartphone).

Privacy of taking HIV medication was assessed via 4 dichotomous (yes/no) questions (e.g., “I don’t want people to see me taking my HIV medication”), and stigma and discrimination were measured by one question: “How concerned are you about experiencing stigma or discrimination related to taking injectable HIV medications?” (not at all concerned, a little concerned, somewhat concerned, very concerned).

All participants were invited to participate in qualitative exit interviews to obtain feedback regarding LA CAB/RPV injections and their treatment setting preference. Exit interviews were conducted by author J.W. with 14 participants between September 2022 and December 2023, with interview timing dependent upon when the 12-month intervention ended for each participant. Interviews were conducted in English over videoconference and lasted between 4–13 min. Participants were compensated $50 for completion of each exit interview.

Data analyses

The results of the end-of-intervention survey were analyzed quantitatively, with descriptive summaries of the results reported. Exit interviews were deidentified and transcribed verbatim. Following transcription, interviews were analyzed using a grounded theory approach. ^14,15 A “ground-up” approach involves an iterative process of establishing codes, grouping the codes into key concepts, and organizing the concepts into broader themes. NVivo software (Version 14) was utilized to organize the data and conduct the qualitative analyses. This software package facilitates coding, storage, retrieval, and analysis of large amounts of transcribed data. The codebook was created in a collaborative, iterative process. Exit interviews were coded by a primary coder (author A.M.), and 25% of exit interviews were double coded for interrater reliability (author R.H.). Inconsistent codes for each transcript were resolved through discussion to reach a consensus.

Results

Descriptive characteristics

Of 26 participants who completed post-intervention surveys, the median age was 47 (range 28–71), 19 were male (73%), and 14 were Black (54%) (n = 12 White, 46%). Regarding employment, 35% were employed full-time, 12% part-time, 38% were unemployed, and 15% reported “other.” Regarding housing, 58% owned a house, 23% rented, 4% lived in a group home, 15% stayed rent-free with friends or family, and 27% lived in a rural area. Almost half of respondents (46%) reported excellent overall health, and 54% reported very good or good overall health. Of 14 participants who completed end-of-intervention interviews, the median age was 48 (range 30–65), 10 were male (71%), and 6 were Black (43%) (n = 8 White, 57%).

Quantitative end-of-intervention survey results

Of participants who completed the end-of-intervention survey, 100% reported that LA CAB/RPV treatment met their needs for treating HIV, that LA CAB/RPV was appealing, and that they liked the injection for treating HIV; 88% reported that the injectable treatment was a good match for their life. Regarding benefits, participants reported the benefits of not having to take pills every day (88%), that monthly injections were more convenient (62%), the benefit of not having to hide oral ART from others (35%), not having to go to the pharmacy to pick up oral ART (38%), reduced stigma compared to taking oral ART (27%), alleviated trouble of swallowing pills (27%), and that injectable treatment had less side effects than oral ART (19%). Only a few concerns for injectable HIV treatment were endorsed, including pain/soreness of the injection (54%), having to travel to the clinic every month to get the injection (12% of all respondents), and challenges finding parking at the clinic (8%). 86% of participants responded it was very easy or easy to get to the clinic for injections, and 62% of participants reported spending less than 30 min for clinic injection visits. No participants reported that they had trouble accessing injectable therapy through their insurance company. When asked about their preferred method of HIV treatment after completion of the intervention, 54% stated injections in the clinic, 38% indicated injections at home, and 8% stated oral treatment, with convenience (71%) and privacy concerns (21%) cited as the most common rationale for their preference. Participants reported that they preferred reminders about upcoming injection visits via text messages (48%) or phone calls (39%).

When asked about concerns or stigma, 42% of participants reported they did not want people seeing them take HIV medication, 15% were embarrassed to get medication from the pharmacy, 39% were reminded that they have HIV by taking medications, and 23% lived with people who were unaware of their HIV status. 39% of participants reported concern about experiencing stigma or discrimination related to taking injectable HIV medications. Participants felt that their current treatment was very controlled (96%), very convenient (96%), and very flexible (92%), and 96% would recommend injectables to someone being offered HIV treatment.

When discussing overall difficulties they were currently facing in general, participants reported there were not enough staff who could help address mental health issues (8%), long distances to medical facilities (23%), lack of transportation to facilities (8%), lack of supportive and understanding work environments for people living with HIV (8%), lack of affordable housing (27%), lack of personal financial resources (23%), and community residents’ stigma against persons living with HIV (12%).

Qualitative results

Six overarching themes emerged from the semi-structured interviews, including: (1) strengths of LA CAB/RPV injections; (2) negatives of LA CAB/RPV injections; (3) treatment setting preference; (4) reasons for preferring LA CAB/RPV injections at home; (5) reasons for preferring LA CAB/RPV injections in the clinic; and (6) general impressions of LA CAB/RPV injections.

Theme 1: Strengths of LA CAB/RPV injections

All participants discussed overall strengths of LA CAB/RPV injections, with the main reasons including that they enjoyed the convenience of LA CAB/RPV injections, did not have to take pills or worry about forgetting to take pills every day, didn’t experience significant side effects with LA CAB/RPV injections, injections saved time or were more manageable than taking pills daily, and they felt strong support for LA CAB/RPV injections from providers. In discussing the convenience of LA CAB/RPV injections, one participant reported, “I, myself, thought that it would be a more convenient approach other than a day-to-day daily regimen. It was better for my schedule and where I have arrived in life.” Another participant reported, “It changed my daily life for the fact that I don’t have to think about it at all.” Every participant that was interviewed discussed not wanting to take pills every day, with one participant stating, “It’s hard for me to swallow pills. I hate pills. Just give me a shot and get it over with.” Another participant described, “I have grown weary of taking almost 18 pills a day.”

Several participants discussed the benefits of not experiencing side effects with the LA CAB/RPV injections, such as “You don’t feel nauseated and all those other side effects that can come with pills, no loss of appetite. It has been wonderful.” In describing that the injections save time or were more manageable than taking pills daily, one participant stated, “(The injections) have done wonders for me. I’m not taking almost 20 pills every day, so it has helped give me some time back. I do not have to worry about going to the pharmacy to pick up those or home delivery. It opened up my scheduling, which has been a blessing.” Another participant discussed how manageable the injections are, saying, “It changed my daily life just for the fact that I don’t have to think about it at all,” and “I don’t have to worry about missing a pill or anything like that.” Finally, some participants discussed the support for LA CAB/RPV injections from providers. One participant described, “(The providers) talk to me through every injection and just made me feel comfortable all around. Everything has just been one positive thing after another,” while another participant said, “The doctors were very patient with me.”

Theme 2: Negatives of LA CAB/RPV injections

About half of the interviewed participants discussed negative aspects of LA CAB/RPV injections, with the main subthemes including pain when receiving the shot or other side effects, fear or anxiety around the injections, and having less responsibility when receiving LA CAB/RPV injections over taking other pills for their health. Specifically, about half of participants reported side effects, such as pain when receiving the shot. One participant reported, “The viscosity of the liquid is thick, so it’s hard going in, and that causes discomfort”; another participant stated, “I always have pain after the injection that lasts for about 24 h. I feel like I’ve been kicked by a horse on that one side every month.” A few participants discussed fear or anxiety around the LA CAB/RPV injections, including comments like “I was a little worried at first because I have never done any type of injectables, so I didn’t really know how it would work compared to taking a pill every day;” and “Experimental is always, you know, questionable and leaves questions in your mind.” Finally, one participant discussed less responsibility when taking the injectable, stating, “It made it difficult to take all my other medications. I had to get back into that habit of remembering to do that again.”

Theme 3: Treatment setting preference

Four participants reported that they preferred receiving their LA CAB/RPV injections in the clinic, and 10 reported that they preferred at-home administration, which matched where the subset of interviewed participants were receiving LA CAB/RPV at the end of the intervention. When discussing LA CAB/RPV injections in the clinic, one participant stated, “I have been going to the clinic since (the early 2000s) when I was diagnosed, and the frequency back then was more than now. I like driving to the clinic to get it done.” Another participant described their reasoning for injections at the clinic by stating, “Like if something’s going to happen, like a reaction or anything dealing with the shot, I was already there, and they can treat me or monitor me.” Stated reasons for preferring the LA CAB/RPV injections at home included convenience and avoiding travel to the clinic. One participant described, “I like the injectables at home. I live a distance from the clinic so scheduling a time to get to the clinic and get back, I can avoid all the pitfalls of the traffic.” All participants who received LA CAB/RPV injections at home described that home injections were convenient and that they highly preferred receiving them at home.

Theme 4: Reasons for preferring LA CAB/RPV injections at home

Participants described several reasons that they preferred the LA CAB/RPV injections at home, including avoiding the travel to the clinic, saving time, feeling safer taking the injection at home, and the convenience of receiving the LA CAB/RPV injections at home. Regarding travel and distance to the clinic, one participant stated, “I live all the way out there, and the clinic is downtown. That’s a lot to drive, parking is jacked up,” while another participant described, “I avoid the challenge of getting back and forth to the clinic. It saved me a lot of time, gas money, and sitting in traffic.” When discussing the time saved by receiving the injections at home, one participant said, “It just gave me more time to spend with my family at home and made it easier to schedule with work if it was in my home, as opposed to having to take the lump of time out to go down to the clinic and come back.” Finally, one participant described the safety of receiving injections at home by stating, “I don’t like to be taken from the comfort of my house back into the chaos of the hospital. There is nowhere else that I know COVID is at. It’s in the hospitals.”

Theme 5: Reasons for preferring LA CAB/RPV injections in the clinic

Reasons participants preferred receiving the LA CAB/RPV injections in the clinic included maintaining privacy from family and that they were already visiting the clinic for other appointments. In discussing privacy from family, participants described that some family members may not know about their diagnosis, and thus, they may not want someone coming into their home to administer the injections. Specifically, one participant described that her child does not know about her medication regimen and stated, “I do not want to sit here and go through all the questioning and explaining to them about mommy getting shots and injections here at home.” Two participants described that they are already visiting the clinic for other appointments, stating, “It was more convenient, me being able to come, and I’m able to see my doctor at the same time as getting my shot.”

Theme 6: Continued LA CAB/RPV injections at home

All participants that completed exit interviews after receiving LA CAB/RPV injections at home described positive impressions, and several specifically discussed that they would like to continue receiving LA CAB/RPV injections at home. One participant described, “I hate that it was just a study. I really need to write my congressman. I’m angry from the time I step out the door to the time I step back, just straight mad, because I gotta drive downtown. To take me from the comfort of my house to back into the chaos of a hospital.” Another participant stated, “It was the best option I had since being diagnosed with HIV,” showing the impact of receiving the LA CAB/RPV injections at home.

Discussion

The overall objective of this study was to capture the voice of participants who chose to receive LA CAB/RPV at home or in clinic in a recently conducted non-randomized observational intervention and to examine the rationale for their preferences and personal experiences. Quantitative surveys conducted at the end of the 12-month intervention shed insight into participants’ opinions about injectable treatment for HIV, their likelihood to continue this modality of therapy, and their treatment setting preference. Participants reported on satisfaction with their current treatment, barriers to taking daily HIV medications, and other existing difficulties they were experiencing related to HIV and care. Qualitative exit interviews performed to further understand the experience of participants revealed that injectable therapy was overall viewed very positively, specifically that it was safe, convenient, and effective, and that it met participant needs regarding treatment for HIV. Importantly, the vast majority (96%) indicated they would recommend injectables to someone being offered HIV treatment. These findings are similar to qualitative findings that examined the acceptability of injectable cabotegravir to prevent HIV in the ÉCLAIR trial, which identified high satisfaction among participants, despite the occurrence of some side effects like injection site reactions. ¹⁶ The interest in home receipt of injectable treatment identified in this study parallels interest reported in home-based receipt of injectable psychoactive therapy for treatment of mental health, ¹⁷ suggesting generalizable interest and feasibility in home-based treatment in distinct cohorts of individuals. ¹⁸

In addition to overall positive impressions regarding injectable treatment, a few concerns were noted, including pain at the injection site, some anxiety about this therapy modality, and transportation challenges given the distance to a medical facility. Reasons for preferring at-home administration centered around convenience and not having to travel to a clinic. In contrast, those preferring clinic administration cited concerns about privacy and potential stigma related to having others know about their HIV status. These findings are similar to results from a qualitative study that evaluated preferences for receiving at-home injectable pre-exposure prophylaxis for HIV prevention, which identified convenience and flexible scheduling with a home-based model but identified concerns of privacy in the home from roommates and neighbors. ¹⁹

Limitations of the study include the small sample size of persons completing the end-of-intervention surveys and exit interviews, which limited our capacity to evaluate for significant differences between those receiving treatment at home versus in clinic and indicating the presented data may not fully capture the opinions of the entire cohort. Another limitation was our ability to only offer this at-home intervention to patients in the three closest counties to the clinic site, which may have influenced study enrollment, as those with the largest transportation inconveniences may not have had the opportunity to participate. ¹³

Despite these limitations, this study identified high satisfaction with receiving injectable therapy for HIV and suggests home administration of injectable therapy for HIV holds promise as an alternative option for receiving treatment for some patients compared to standard in-clinic treatment. Having diverse options for where and how to receive injectable HIV therapy could help increase access and availability of this therapeutic modality, especially for those living at significant distances or who may have reservations about frequently visiting a medical facility.

Data Availability

Available from the corresponding authors upon request.

Author Disclosure Statement

E.G.M. has previously served on an expert panel for ViiV Healthcare. V.F. has previously served on an implementation science advisory panel for ViiV Healthcare. No other authors have conflicts to report.

Funding Information

This study was funded by ViiV Healthcare. This study was also supported in part by the Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services (HHS) as part of the National Telehealth Center of Excellence Award (U66 RH31458) and the South Carolina Clinical & Translational Research (SCTR) Institute (NIH/NCATS Grant Number UL1 TR001450). EGM has received support from the NIGMS of the National Institutes of Health (P20 GM130457).