Background
Methods
Study design
Study population
Ethics, consent, and permissions
Study instrument
I. Drinking History | |
A. Tell me about your experience with drinking alcohol | |
1. At what age did you first start drinking? 2. When you first started drinking, were you a light, moderate, or heavy drinker? 3. Why did you decide to start drinking? a. Traumatic experience, social drinker, stress, anxiety, depression … 4. What was it about alcohol that made you continue to drink? 5. Have you tried to quit drinking? b. Tell me about your previous attempts to quit i. Successful or Unsuccessful ii. Time period that you were able to quit or reduce your drinking iii. Were there any barriers that stopped you from quitting or reducing drinking? II. Study Participation* A. How did you find out about the study? 1. What was it about the study that motivated you to participate? 2. Tell me about your participation in other research studies, if any? B. What benefits do you get out of participating in research? C. Tell me about your experience in this study 1. What were some things that you like about the study? 2. What were some things that you did not like about the study? a. What was difficult? D. Describe your relationship with the study staff 1. What did you like about the study staff? 2. What did you not like about the study staff? III. Changes as a result of participating in the WHAT-IF study A. What changed in your life as a result of being in the study? 1. How were you able to quit or reduce drinking? a. If so, why do you believe you were successful in doing so? i. Do you think that the study medication helped to reduce or not reduce your drinking? ii. Do you know if you were taking naltrexone or the placebo? b. If not, why do you believe you were unsuccessful? 2. Besides drinking, what else changed in your life as a result of being in the study? B. What do you think are the barriers (things that keep you from doing something) or the facilitators (things that help you do something) to this treatment that would exist in the real world outside of a research setting? IV. Support A. Did you have any support from family, friends, etc.? B. When you think of someone that is being supportive, what are they doing? 1. Before being in the study, who did you receive support from? a. In what ways were they supportive or not supportive of you wanting to quit or reduce drinking? 2. During the study, who did you receive support from? a. In what ways were they supportive or not supportive of you wanting to quit or reduce drinking? 3. After completing the study, who did you receive support from? a. In what ways were they supportive or not supportive of you wanting to quit or reduce drinking? C. How important do you think it is to have support? 1. Who do you think are your best providers of support? a. Family, friends, healthcare providers, etc.? 2. Do you think that support is needed in order to successfully quit or reduce drinking? a. Why or why not? | |
V. Next steps A. Now that you have completed the study, what would you recommend the research staff do next? 1. What could be done differently in the study? B. If you were going to give advice to women about quitting or reducing their drinking, what would you tell them? C. Additional information: 1. Would you like to add anything else? |
Procedure
Data analysis
Results
Characteristics | (N = 20) |
---|---|
Demographics, No. (%) | |
Age range, years | Mean 49.3 |
Race | |
Black/African American | 17 (85) |
White | 2 (10) |
Other | 1 (5) |
Ethnicity | |
Hispanic/Latino | 1 (5) |
Non-Hispanic/Latino | 19 (95) |
Education Level | |
Less than High School | 12 (60) |
High School Graduate | 4 (20) |
Some College | 4 (20) |
Marital Status | |
Single | 16 (80) |
In a relationship | 4 (20) |
Biopsychosocial Factors | Reasons for study participation | Clinical trial experience (positive or negative) and retention in study |
---|---|---|
Biological | • To reduce drinking to nonhazardous levels • To quit drinking | • Study medication |
Psychological | • To gain knowledge about the negative effects of hazardous drinking on HIV disease progression • The opportunity for self-reflection or self-growth | • Thoughts and feelings toward study procedures (e.g. study medication, lab work, computer-based assessments) • Length of study |
Social | • To feel pressured by members of social network • To earn supplemental income | • Interactions with research study staff |
Reasons for participating in the WHAT-IF? Study
Biological
“I started drinking every day, and then sometimes I would drink too much the night before, like six beers or something, and in the morning, I’d need a beer badly … but I joined this study because I was interested in helping myself slow down.” (female, 50-60 years old, non-Hispanic White, single)
“It’s (clinical trial participation) supposed to help me stop or at least slack up. It’s supposed to help me to stop drinking. At the time, I was all for it, something that’s going to help me stop drinking.” (female, 30-40 years old, non-Hispanic Black/African American, single)
Psychological
“I knew I would get information to help me slow down on my drinking, at least quit my drinking or slow down on it … ” (female, 50-60 years old, non-Hispanic White, single)
Additionally, the women believed participation in the study provide the opportunity for self-reflection by allowing them to examine their life and recognize the areas that they would like to incorporate changes.“Because I also wanted to learn what the study was about. I’m always in to learning something new.” (female, 40-50 years old, non-Hispanic Black/African American, single)
“Reasons why I went into the study in the first place – to find myself, why am I doing this stuff to myself, you know?” (female, 50-60 years old, non-Hispanic White, single)
“I think it gave me time to reflect on the way I had been and where I’ll wind up at until where I am now. I wasn’t a drinker. I got into this relationship. He was a drinker, so just being a part, I started drinking.” (, female, 40-50 years old, non-Hispanic Black/African American, single)
“The way I was carrying my life, and I wanted my life to be better. That’s why I participated in the program.” (female, 50-60 years old, non-Hispanic White, single)
Social
“I was talking to some of the other ladies, and I heard them talking amongst themselves trying to be confidential, and they were talking, “Girl, I’m going to this [name of clinical trial].” “Girl, they pay you to stop drinking.” (female, 50-60 years old, non-Hispanic White, single)
Also, many women reported being influenced or pressured by members of their social networks (e.g. family, friends) to participate in the study as a way to manage their problem drinking.“Through a friend. She told me about it. She gave me the phone number to call, and I asked her what it was about. She said it was related to alcohol. She said she knew I drank, so I found out through a friend.” (female, 50-60 years old, non-Hispanic Black/African American, in a relationship)
“A friend told me that they got an alcohol study going on, and told me to go. She says if I didn’t go there, she’s going to take me there, either that or AA.” (female, 50-60 years old, non-Hispanic Black/African American, single)
Though the majority of the women in this study were unemployed, participating in the study provided the opportunity to earn supplemental income.“My sister. She just kept telling me, “Sis, I think you need to get into this program; it’s something good.” I said, “Girl, I don’t want to get in that. Don’t tell me anything about that.” She kept talking to me; “Sis, you need to get yourself together.” I said, “Okay, I’ll try it.” (female, 50-60 years old, non-Hispanic Black/African American, single)
“I was motivated because I saw a lot of people going. Do you know what I mean? Now I got paid to go. I found myself when I got paid to go, I said, “God was doing for me what I couldn’t do for myself.” I used to pray about things that I wanted to stop doing.” (female, 50-60 years old, non-Hispanic black/African American, single)
“Just money because I am on a fixed income … ” (female, 50-60 years old, non-Hispanic Black/African American, single)
“Well, I had issues at the moment, I needed a couple of dollars too. So it was – they helped me and I helped them. I gave them what they needed and they gave me some money.” (female, 30-40 years old, non-Hispanic Black/African American, single)
Experience and retention in the WHAT-IF? Study
Biological
“The medication, it worked.” (female, 40–50 years old, non-Hispanic Black/African American, single)
“Excellent. It was actually because I didn’t have – there was no side effects. (female, 40–50 years old, Hispanic, single)
“The medication wasn’t a problem because – I think I became immune to taking meds, (laughs) I’m just going to say because I have to take meds, my little regiment that I have to take. The pills wasn’t a problem.” (female, 40–50 years old, non-Hispanic Black/African American, single)
“It made me sleepy all the time. I would have to take it once a day so I would take it at night because it’s gonna’ put me to sleep. At first I started having these headaches from it, then I was nauseous but I got used to taking it.” (female, 40–50 years old, non-Hispanic Black/African American, single)
“Them things [pills] make me feel like my skin was on backwards.” (female, 50–60 years old, non-Hispanic Black/African American, single)
“As far as the pills are concerned, I was tired of taking those pills. It was toxic. Knowing that I had the virus I had eliminated a lot of toxins, so sometimes I wouldn’t actually take all the pills that they provided for me. Sometimes they would hit the commode, you know, because I was taking other HIV medications, high cholesterol, and so forth and so on. That’s toxic, you know, and I had to eliminate a lot of toxins from my body. After all, I was drinking and I wanted to get rid of that. With all those different types of pills, it’s like a bomb. It can blow with alcohol. I could blow up and not be anything and maybe get on dialysis or something, you know?” (female, 50–60 years old, non-Hispanic Black/African American, single)
Psychological
“Like I said, I don’t know if I was getting the real thing or the phony thing, but I think mentally, because I felt that it was helping me, I was actually helping myself.” (female, 50–60 years old, non-Hispanic Black/African American, single)
“Ah I liked it because it kept me aware it made me think you know you have to be careful now you taking these pills you don’t want the medication to react with the alcohol so the pills kind of kept me like ah ok now you don’t know what this stuff is you’re taking.” (female, 50–60 years old, non-Hispanic Black/African American, single)
“When I first started taking the medication, it was up and down with me – up and down. Some days, maybe at the end of the month, I forgot to take the medication. What I had to do was put it on an alcohol beverage; to say, “You need to take this. Maybe this will help you.” That’s basically how it helped me to remember to take the medication.” (female, 40–50 years old, non-Hispanic Black/African American, single)
“I didn’t like the medication.” (female, 40–50 years old, non-Hispanic Black/African American, single)
“The medication I really didn’t want to take it.” (female, 50–60 years old, non-Hispanic Black/African American, single)
“I have no complaints. They gave me that pill. I didn’t like that, but I don’t like taking medication. So it wasn’t just – even though I’m positive, I don’t like taking pills.” (female, 30–40 years old, non-Hispanic Black/African American, single)
“I hate getting’ stuck because they can’t stick me one time they have to stick me more than once because I have these old baby veins. I have to always get stuck more than once, twice mostly more than twice.” (female, 40–50 years old, non-Hispanic Black/African American, single)
“Yeah, drawing blood. They had a heck of a time drawing my blood. I am a hard stick, figuring out these little thin, spider webby veins. They’re so tiny– it was just terrible. I had to drink a lot of water. One time they had to do me six times to get my blood.” (female, 50–60 years old, non-Hispanic White, single)
“I like answering the different questions on the computer. I like when they asked me how long I had been going before I had a drink you know different questions they were asking me. I can’t remember per se you had them in steps.” (female, 50–60 years old, non-Hispanic Black/African American, single)
“The questions, they were personal questions. You know, what led me to drinking? Was it something? Was I depressed? Was I going through some type of changes? So that made me look at me. It was short, but it was interesting.” (female, 40–50 years old, Hispanic, in a relationship)
“That was fun to a certain extent. They were just so goddamn long. I don’t have patience that long. The only patience I have is sitting down reading the good books that I read.” (female, 50–60 years old, non-Hispanic Black/African American, single)
“Actually, it was a very convenient study so it wasn’t taking me out of nothing else I was really doing. I’d just go to the study, and then I’d go do whatever I was doing. It was very convenient. The time, I got to meet new people – you know, a couple people in there. It’s not far from my house, so it’s convenient.” (female, 30–40 years old, non-Hispanic Black/African American, single)
“It wasn’t a long, drawn out study. I mean because don’t wear me out …” (female, 30–40 years old, non-Hispanic Black/African American, single)
Social
My good experience is just sitting down and like what I’m doing with you now, but kind of different, just discussing my drinking, and how I drink, and how much I drink. Even though we’re talking about that, I was able to go outside of the boundaries a little bit and express my feelings or something personal, and the recruiter was open and there just to listen. That was good for me. (female, 40–50 years old, non-Hispanic Black/African American, single)
“I love the staff. The staff welcomed me. I felt comfortable and safe. I could talk to them about what’s going on with me. They were more like my listeners, not just only an employee, and they allowed me to be myself, and they treated me with respect, regardless of what my past was. I felt comfortable.” (female, 40–50 years old, non-Hispanic Black/African American, single)
“I like the people. They’ll pull you away. They draw you to them. They try to solve your problems. They try to keep you in firm. I just like it.” (female, 50–60 years old, non-Hispanic Black/African American, single)
Actually, it was the encouragement because I know that research is about we’re going to get this data, and we’re going to pay you, but staff members from the study that were actually caring. I noticed there were questions that were not written on the paper. So to me, that showed me there was some kind of feeling there of care, and they would listen to everything I had to say. It wasn’t a rush or anything like that. (female, 40–50 years old, Hispanic, single)
“Only sometime, when I felt they was in [a hurry] but I was in my own hurry. When you get there, you have things planned out. Here they are, running a little late, and so it was me. I was in my own hurry.” (female, 40–50 years old, non-Hispanic Black/African American, single)