Background
Opioid antagonist therapy for individuals with HIV and opioid use disorder
CTN-0067 CHOICES study
Main text
Methods
VARIABLE | PARTICIPANTS (n = 26) |
---|---|
Age | |
20–29 | 3 |
30–39 | 11 |
40–49 | 6 |
50–59 | 3 |
60–69 | 3 |
Gender | |
Women | 19 |
Men | 6 |
Transgender | 1 |
Educationa | |
Some college | 1 |
Technical/associate degree | 2 |
Bachelor | 2 |
Master | 8 |
PhD | 5 |
MD | 10 |
Study role | |
Site PI | 4 |
Study clinician | 7 |
Study coordinator | 8 |
Research assistant | 5 |
Outreach worker | 1 |
QA monitor | 1 |
Years at clinic | |
1–3 | 8 |
4–6 | 5 |
7–9 | 2 |
10–12 | 3 |
13–16 | 5 |
17–19 | 0 |
20+ | 3 |
Years experience with HIV or SUD | |
1–3 | 4 |
4–6 | 6 |
7–9 | 2 |
10–12 | 2 |
13–16 | 6 |
17–19 | 2 |
20+ | 4 |
Years experience with MOUD | |
1–3 | 15 |
4–6 | 4 |
7–9 | 1 |
10–12 | 3 |
13–16 | 2 |
17–19 | 0 |
20+ | 1 |
Results
Theme | Specific barrier | Quote | Potential Actionable steps |
---|---|---|---|
1. Eligibility Criteria | Suppressed HIV viral loads | People that are showing up to an HIV clinic even sporadically have a very high suppression rate. 85 to 90%, because the medicines have just gotten so much easier. It really is hard to find these folks if you are sitting in the clinic. | Consider broadening eligibility criteria to include individuals with unsuppressed HIV or drugs of choice in a specific community. Peer outreach workers or partnering with other organizations can be helpful recruitment opportunities. |
Opioids not the primary drug | There’s not as many opioid users at least here as in other parts [of the country]. Among [our] population, [there is] more methamphetamine use. | ||
2. Stigma | Fear of learning HIV status | The stories of people’s fears when we talk about their diagnosis experiences and we talk about their reactions and disclosures and all of that it’s like we’re back in the 80s, early 90s. Especially in [our rural community]. | Ensure that staff are well trained on the stigma that patients feel and can respond in manner that makes them feel comfortable in the clinic. |
Fear of others learning their HIV status | Because if you live in a town of a couple thousand people, it’s very ‘somebody that knows somebody that knows somebody’ sees you walking into this [HIV] clinic. This is why we have people driving several hours one way to come here. It gets incredibly difficult to even locate individuals who may be susceptible, who may be in need of MAT | ||
Internalized stigma and self-shaming | It’s kind of this self-shaming thing like ‘I did it to myself, I deserve to have [HIV].’ There’s a lot of cultural stigma and shame surrounding HIV and Hepatitis C.…People often report their substance use and do not tell me that they tested positive for Hep C or HIV. | ||
3. Research complexities | Lengthy procedures | The [patients] are [thinking], ‘I’m sitting here for three hours, I could be out on the street making money to get well.’ At this point a lot of them don’t even enjoy the high, but they have to keep using to not get sick. | Ensure that the research procedures are as streamlined as possible while providing adequate time to answer all questions and concerns. |
Fear of research and outsiders | The older generation especially the older black men. Definitely. They are like … remember what happened … when they gave all those black men syphilis? How will I know you are not doing that? | ||
4. Patient preferences | Treatment preference | I’ve had people who were randomized into treatment as usual [say] ‘I was looking forward to getting the injection’ and vice versa. | Provide all of the information to the patient about the pros and cons of each medication. Make sure they are comfortable with either study condition prior to randomization so that study resources are used for patients who are willing to follow through for either arm. |
A lot of patients still view [buprenorphine] and methadone as opioids ... Once they understand what [XR-NTX] is, they don’t see that as a quote dependent drug. Some people actually preferentially desire to get onto [XR-NTX] … | |||
Concerns about withdrawal | When I describe precipitated withdrawal, people say, ‘Oh, is that like what happens after I use [naloxone]?’ If they have ever done that they are petrified of using [XR-NTX] because they never want to feel like that again. | ||
5. Social and structural barriers | Housing and transportation | [Patient] had housing issues and that seemed to take priority before being able to stop using because she couldn’t go to inpatient just yet because she didn’t feel secure with her housing situation. | The extent possible, assist patients with wrap-around services such as housing referrals or transportation services. Understand any criminal justice involvement and how to track them should they become incarcerated. |
Mass transit in [our community] is not great. Buses run late, there’s lots of traffic. … you have to make so many connections and when you combine the amount of time and the amount [of] delays, it’s very hard for people to make appointments on time. | |||
Criminal justice involvement | You could be sitting with them doing an assessment and then the next minute they walk out of your office and boom, they are arrested, you know, you-- it’s a revolving door. |
Eligibility criteria
Suppressed HIV viral loads
Our viral suppression rate for our HIV patients is about 81, or 82 percent so, I mean, we have a high viral suppression rate.
For us it's a gigantic learning curve to figure out how to reach out into the community because we've really depended on patients walking through our door. [For this study,] we can't wait for patients to come in.
People that are showing up to an HIV clinic even sporadically have a very high suppression rate. You know, 85, 90 percent, because the medicines have just gotten so much easier. It really is hard to find these folks if you are sitting in the clinic.
Opioids not primary drug in the community
There's not as many opioid users at least here as in other parts. Among this population, [there is] more methamphetamine use. I think while it's looked at nationally, there are regional differences.
Stigma
Fear of learning HIV status
The stories of people’s fears when we talk about their diagnosis experiences and we talk about their reactions and disclosures and all of that it’s like we’re back in the 80s, early 90s. Especially in [our rural community]. People feel like they have to bleach their bodies, because they’re dirty.
Fear of others learning of their HIV status
I can’t tell you how often in the clinic I hear someone saying ‘Well you can’t send any mail to my house that might come from the clinic, and you can’t send my medicines to that pharmacy because the guy who works at the pharmacy knows my cousin and the whole county will be talking.’ Everybody’s up in everybody’s business. It even affects how we communicate results.
It's very hard for the people in our community to walk in our door thinking that someone is going to find out that they have HIV. That's why when we are recruiting people we are … using the substance use problem as the way to get people in. We will screen them when they are here if they have HIV.
Internalized stigma and self-shaming
Respondents sough to overcome these uncomfortable feelings with a welcoming and safe environment.It's kind of this self-shaming thing like ‘I did it to myself, I deserve to have this’. There's a lot of cultural stigma and shame surrounding HIV and Hepatitis C. I've found less reported shame surrounding substance misuse disorders. People often report their substance use and do not tell me that they either tested positive for Hep C or HIV. Or if I ask the question, people tend to shut down and that takes longer for me to get that history than the substance use history.
Research complexities
Lengthy enrollment procedures
It takes less time if we do it all at once. … [I could say] ‘We can do this part on one day, and you can come back a few days later and we can do this part. Then it’s less time for each visit.’ With this population, you can’t do that. If you say, ‘Hey come in for this part today and then in a couple days when you have more time you can come in and do this next part,’ they’re just gone.
That’s one of the better recruitment methods that we have going for us right now is our internal referrals. If it’s a person who has fallen out of care, they’ll send a message that says ‘hey, so-and-so is in the hospital’.
Fear of Research and outsiders
Another respondent echoed these experiences, noting that potential participants ask “Well what about Tuskegee? People are experimenting on us.” Staff worked to overcome this barrier by slowly developing trust and rapport and by communicating how potential subjects will be protected.I know the people that I talk to; they always feel like black people are being targeted … The older generation yeah, they all complain about research studies. Especially the older black men. Definitely. They are like -- I guess they don't really know their names-- the Tuskegee study -- but they are like remember what happened with all those black men when they gave all those black men syphilis? How will I know you are not doing that?”
I just say ‘I appreciate you respecting me and trusting me enough to listen and learn more about the study to just make a better decision’ … They are starting to be more open.
There’s skepticism about the university in [our] community; it’s like a research institution so they’re already a little bit on guard when you’re trying to do this kind of research. It’s just huge.
The needle exchange has been a god send. People come to them to exchange needles and … they have HIV testing. Once an HIV positive individual is identified, they immediately contact us.
Patient preferences
When respondents were asked how individuals formed these opinions and preferences, a research assistant explained, “I think a lot of it is community-based knowledge,” and that “word of mouth can have tremendous impact.” In one case, a patient randomized to XR-NTX did not have a positive experience and shared this liberally within her community. The research associate commented that this early participant had a negative impact on subsequent recruitment as “that word spread and made other people leery”.I've had people who were randomized into TAU and were like ‘I was looking forward to getting the injection’ and then vice versa. We've had some TAU's that are like ‘Okay, you know, this is an opportunity, let me take advantage of it’ and the same goes for [XR-NTX].
Study staff have worked to overcome these concerns by discussing non-opioid pain management alternatives.I’ve had a couple of patients who were like “What if I need a dental procedure?” or “What if I have to have surgery and I’m on this medicine?” So that’s going around too.
Substituting a “drug for a drug”
A lot of patients still view [buprenorphine] and methadone as opioids and depending on something. Once they understand what [XR-NTX] is, they don't see that as a quote dependent drug. Some people actually preferentially desire to get onto [XR-NTX] … and, despite all odds, manage to get on it.
Concerns about withdrawal. Participants randomized to the XR-NTX arm must be opioid free prior to induction to prevent precipitated withdrawal. Patients’ concerns about opioid withdrawal symptoms were recruitment barriers: A lot of our OUD clients have an intolerance of distress and pain and feeling uncomfortable. They’re just not ready to make that leap.
When I describe precipitated withdrawal, people then will say, ‘Oh, is that like what happens after I use [naloxone]?’ If they have ever done that they are petrified of using [XR-NTX] because they never want to feel like that again.
Most of the patients that we have, when they come to us they’re super interested in [buprenorphine] because … there is a black market and illicit street use for [buprenorphine]. A lot of people are treating themselves. They see their community dying from heroin and from fentanyl overdoses and they get scared. They buy [buprenorphine] off the street from their friend and treat themselves … People … have experience with buprenorphine. They know it works. They know they feel normal on it. They know they don’t have withdrawal if they do it correctly.
Social and structural barriers
Housing, communication, and transportation
There is no routine to their life so sometimes you know, weekends run into weekdays and they might not really remember that they have an appointment There's no way to contact them to remind them, you know? Something as basic as that; they just don't have a way to remember.
A clinician explained that in her clinic, recruiters “might have hooked in with somebody but then the housing falls through and then we lose them”.Turbulent living conditions were considered to be a universal barrier to recruitment: “Home is not a safe place for a lot of people and so asking someone to be there when there's all of the same kind of stressors and inducement is really challenging”. For some, addressing chaotic home situations takes precedence over treatment. [Patient] had housing issues and that seemed to take priority before being able to stop using because she couldn't go to inpatient just yet because she didn't feel secure with her housing situation.
Mass transit in [our community] is not great. Buses run late, there's lots of traffic. It takes a long time to get from point A to point B because you have to make so many connections and when you combine the amount of time and the amount [of] delays, it's very hard for people to make appointments on time.
Some sites also utilized rideshares such as Uber and Lyft to address transportation barriers.We transport them ourselves in this van. I can't imagine having to set that up at the beginning of this trial. It's something that took a lot of time and effort to figure out and thankfully it worked well.
Legal system involvement
It's a revolving door with our clients. You could be sitting with them doing an assessment and then the next minute they walk out of your office and boom, they are arrested, you know, you-- it's a revolving door.
We just tried so hard to get her onto the [XR-NTX] shot and she just wasn't ready because of a lot of different things going on in her life and then she was incarcerated.
Readiness to change
A lot of people are scared to stop like-- if I'm sober, if I don't use drugs anymore, then what? So if they can have that support like, this is what we are going to do like the hand-holding stuff-- we are going to do this now.
When they are randomized into whatever group that they are put into, that's when they realize ‘uh oh, no, I don't want to do this’ or ‘I'm not ready’. During the pre-screening, screening, randomization all that section there, they are fine, they are great initially and then when they are faced with-- you've been put in the [XR-NTX] section or the TAU, it's like they start to shuffle. I guess the not readiness or the not decisiveness or their willingness to change
People are dying. People who have successfully been using and doing relatively well, not over-dosing, still alive for thirty, forty years, now are having friends that are dying and have overdosed. Coming and saying I'm scared that I could die, the stuff that's out there is not what it used to be. I got to do something about it.
The motivational interviewing is helpful in getting to that point, in teasing out the information that we would need in order to address any concerns the participant might have in order to help them recognize what their wants are.