| Methods |
Couples (n = 215) were randomly assigned to one of 2 groups: the 4‐session couple‐focused adherence program (n = 106), or usual care through the medical provider of the HIV‐sero‐positive partner (n = 109). A randomization table was constructed from a random numbers list and stratified by couple type. Randomization was conducted by the study's project director while assessors and all other personnel (except for intervention facilitators) were blind to study arm assignment throughout the trial |
| Participants |
Patients were eligible if they were an HIV‐sero‐discordant couple (self report) with a relationship duration of 6 months or more, and both partners were English‐speaking adults (over 18 years of age). The HIV‐sero‐positive partner needed to be in primary care and taking antiretroviral therapy (ART) for at least 1 month. Couples meeting these criteria were scheduled for an in‐person main screening appointment where the couple's relationship status was confirmed by independently asking each partner when and how they met, whether they considered themselves to be in a 'committed' relationship, and whether they expected to be in this relationship for at least another year. Couples returned 2 weeks later and were eligible for the study if less than 80% of prescribed doses were taken within specified time windows during the 2‐week Medication Event Monitoring System (MEMS) observation period |
| Interventions |
The intervention, a 4‐session couple‐focused adherence program, aimed to improve patients' adherence to HIV/AIDS medical care regimens by fostering the support of their partners; in addition, to help couples address their issues of sex and intimacy. The intervention was individually administered to each couple by a nurse practitioner through 4 45‐ to 60‐minute sessions held over 5 weeks. The session content included structured discussions and instruction, as well as specific problem‐solving and couple‐communication exercises. Key components included education about the importance of adherence to avoid viral resistance and maintain health, identifying patterns of non‐adherence, developing communication and problem‐solving strategies to overcome adherence barriers, optimizing partner support, and building confidence in the couple for achieving and maintaining improved adherence. Standard care patients received attention to adherence‐related issues from a multidisciplinary treatment team. Dosing, common side effects, and the importance of adherence to the regimen as prescribed were discussed. Patients were instructed to contact the clinic to speak with either their medical provider or a nurse if they had difficulties with the regimen. Follow‐up with the patient's medical provider usually occurred within 2 to 4 weeks after initiating a new regimen. Any adherence problems were assessed in order to find the underlying causes and the appropriate manner to address them |
| Outcomes |
The primary measure of adherence was the MEMS cap. MEMS data were downloaded into computer software to calculate adherence summary scores for the percentage of prescribed doses taken (without regard to timing) and the percentage of prescribed doses taken within specified time windows (e.g. for twice‐a‐day regimens, intended dosage times were set 12 hours apart, with +‐ 2‐hour windows around each intended dosage time). The adherence summary scores were adjusted through participant self reports of errors in MEMS use. Viral HIV RNA load and CD4 cell count assays at baseline and at week 8 were used as clinical measures. If a blood sample was not given, the patient's medical chart was examined for clinical outcomes within appropriate time intervals. If neither a blood sample nor medical chart data were provided, self reported biomarkers were used |
| Notes |
― |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
The study explicitly refers to a random table. "A randomization table was constructed from a random numbers list and stratified by couple type." (pg 809) |
| Allocation concealment (selection bias) |
Unclear risk |
Randomization was not centralized but done by study director. Although assessors were blinded, it is not clear who were the recruiters and if they were blinded. "Each partner of eligible couples was separately administered the baseline interview prior to randomization." (pg 809) |
| Selective reporting (reporting bias) |
Unclear risk |
No protocol available; although it appears that everything was reported it is difficult to determine this without a protocol |
| Other bias |
Low risk |
The study seems to be free of other types of bias |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Low risk |
(PRIMARY) MEMS ‐ Assessors and all other personnel (except for intervention facilitators) were blind to study arm assignment throughout the trial (pg 809) |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ This is an objective measure and assessors were blinded. "Assessors and all other personnel were blind to study arm assignment throughout the trial" (pg 809) |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) MEMS ‐ Patient could not be blinded to the adherence intervention, and likely they are aware of the purpose of the MEMS cap |
| Blinding of participants (performance bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ This is an objective measure of outcome |
| Blinding of personnel (performance bias)
Adherence measure |
Low risk |
(PRIMARY) MEMS ‐ Assessors and all other personnel (except for intervention facilitators) were blind to study arm assignment throughout the trial (pg 809) |
| Blinding of personnel (performance bias)
Patient outcome |
Low risk |
(PRIMARY) VIRAL LOAD ‐ This is an objective measure and assessors were blinded. "Assessors and all other personnel were blind to study arm assignment throughout the trial" (pg 809) |
| Incomplete outcome data (attrition bias)
Adherence measure |
Low risk |
(PRIMARY) MEMS ‐ Dropout rates are similar between study arms at 8 weeks (primary outcome assessment) |
| Incomplete outcome data (attrition bias)
Patient outcome |
High risk |
(PRIMARY) VIRAL LOAD ‐ A blood sample could not be taken for dropouts at 8 weeks (see snapshot figure 1) We cannot know if the others did. Self reporting of biomarkers could have been biased. Reasons for missing data not reported |
