Design and sampling
The present qualitative study was the first phase of a broader sequential exploratory research conducted in Spain between 2016 and 2018. We interviewed 21 PLHIV who took a diverse type of illicit drugs and had taken ART for at least 1 year. We decided on the profile of PLHIV to be interviewed through theoretical sampling guided by the results of the focus group described in the procedure section. Experts participating in the focus group agreed on the need to interview the following demographic and epidemiological profiles of PLHIV: men, women, different ages, MSM (including sex workers), heterosexual, transgender women, and migrants. Moreover, they agreed with the relevance of including PLHIV who used diverse types of drugs to allow us comparisons in the variables under study. According to previous results in Spain [6], the following patterns of use of illicit drugs were established: (i) Recreational drugs and sexualized drugs. Recreational drugs are those used mostly in night parties such as cocaine, ecstasy, speed, crystal, mephedrone, methylenedioxymethamphetamine (MDMA), gamma-hydroxybutyric/gamma-butyrolactone (GHB/GBL), ketamine, among others; while sexualized drugs are those used exclusively in a sexual context such as nitrites (poppers); (ii) traditional illicit drugs, which are those linked to social exclusion such as heroin or crack cocaine.
Afterwards, we conducted an observational cross-sectional study in which 1.401 PLHIV were recruited from 12 Spanish regions [17]. Lastly, we conducted a multicenter observational retrospective cohort research in which two cohorts of PLHIV who used and who did not use recreational drugs were recruited (N = 275 PLHIV) from four hospitals from three Spanish regions. These studies delved into the research questions and hypotheses posed using different methodological approaches.
This research was conducted using a paradigm of community-based participatory research, so that members of the population under study were directly implicated in all its phases [18, 19]. Thereby, PLHIV were involved in different stages of the study. One of the principal researchers was a person with HIV. Moreover, an advisory group made up of eight experts from diverse disciplines and settings, including community-based organizations linked to the population under study, guided the research, and participated in its different phases. Besides, recruitment and face-to-face interviews were performed by the experts living with HIV members of the advisory group. The research team discussed all findings of the research with the expert community-based advisory board.
The Ethics Committee of the Hospital Clínico of Valencia approved the research protocol. The participants were informed of the objectives of the study and written informed consent was obtained. None of the selected participants refused to participate.
Procedure
Firstly, we conducted a focus group with experts who were working in health-care and in the community. This group discussed the state of the problem under study and delimited the relevant issues to be explored. This focus group lasted approximately 3 h.
Once the group discussed the theoretical contents, we assigned some time to debate with the experts methodological and procedural issues regarding the next steps of the study. Firstly, we designed the specific composition of the sample according to the criteria that they had previously agreed. The group accorded that the four experts that were PLHIV and members of the executive boards of non-government organizations (NGOs) from four Spanish regions (Barcelona, Madrid, Seville, and Valencia) recruited the participants through their NGOs and carried out the face-to-face interviews. This decision was taken based on the fact that their proximity with the interviewees could encourage them to speak confidently about the sensitive issues explored in the interview. Afterwards, we distributed the theoretical profiles of PLHIV among these four experts according to the main profile of PLHIV they attended in their NGOs. Then, the four experts selected potential participants among their NGOs’ users. These four experts were individually trained by a researcher of the team expert in qualitative methodology. The collaborating experts explained the goals of the study to the pre-selected participants, requesting their participation, and obtaining their signed informed consent. Interviews were conducted privately in the NGOs between April and June 2016 and lasted approximately 1 h each. Continued supervision and advice were provided to these four experts while the interviews were conducted.
Instrument
We designed the structure of the script of the interview based on the conceptual framework of the study (Fig. 1). Besides, it was based on the literature about the determinants of health behaviors in HIV [20, 21], on the relevant domains identified by the experts in the focus group, and on the research questions of the study about such domains. The interview script contained the following five sections: (i) Health data and the use of medications. It included questions related to ART and other prescribed medications the participants had; (ii) Drug use. It explored the illicit drugs and other substances that the participants took, the reasons to consume them, the frequency and patterns of consumption, and the relationship between illicit drug use and HIV diagnosis; (iii) Knowledge and beliefs about interactions. It included questions aimed at finding out the interviewee’s degree of knowledge about DDIs, beliefs about it, and communication with healthcare providers about their use of illicit drugs; (iv) Behaviors adopted to alleviate DDIs and the impact on adherence. It explored adherence behaviors and the kind relationship between it and the use of illicit drug use; (v) The impact of drug use on health, QoL and the health system. It contained questions aimed to explore how was the interviewee’s perception of health and QoL, whether they had experienced negative health consequences or had to increase their use of healthcare resources due to the use of illicit drugs. The specific questions asked in the interview can be found in a supplementary file (Additional file 1). The script was reviewed and agreed on by the group of experts and members of the research team. Three initial interviews were conducted in order to pilot the interview. Besides, before the interview, we collected demographic data and limited health data in written form.
Data analysis
We performed content analysis of the interviews [22] using MAXQDA 12 software. For this purpose, the interviews were verbatim transcribed, reviewed for accuracy, and coded. A book of deductive codes was developed, following the map of the design of the study and the research questions [23]. This process allowed us to rate the information saturation in the main topics of the interview [24]. Next, the codes were grouped into categories, which were formed mainly using a theory-driven approach performed by the main analyst. A second researcher then coded 10 interviews (nearly 50%). The mean percentage of agreement of the presence and frequency of categories in each segment was 69.75% (± 7.6) and Cohen’s mean kappa index of agreement was 0.68 (± 0.9). Any inconsistencies among judgements in categorization were resolved by consensus. All the research team reviewed and approved the final categorizations.
To analyze patterns and differences in the categories according to the participant’s profile of use of illicit drugs we used the mixed methods tool of the MAXQDA 12 software. This profile was established according to the findings of Folch et al. [6].
To determine the potential theoretical interaction between the ART and the illicit drugs the participants used, we checked the daily-practice interaction database http://www.hiv-druginteractions.org by the University of Liverpool. We analyzed clinically significant DDIs (moderate and contraindicated), that is, those requiring close monitoring, modification of dosage or adaptation of the therapeutic range of the drugs involved, and those whose combination would be contraindicated due to their potential to cause serious adverse effects. We used the mixed-methods tools of the MAXQDA 12 software to compare the discourses in the knowledge, beliefs, and adherence behaviors according to the DDIs’s participant’s classification.