Background
Analytical Treatment Interruptions (ATI) are required to test the efficacy of HIV cure strategies. However, they are highly demanding on participants and may lead to psychosocial impact. We evaluated concerns, expectations, and satisfaction in participants in two HIV therapeutic vaccine trials that included ATI.
Methods
A total of 72 people with HIV (PWH) entered a 24-week ATI phase: 42 early-treated (AELIX-002) and 30 chronically-treated individuals (BCN03), who were ART-suppressed for a median (range) of 2 (1-3) and 7 (2-15) years, respectively at study entry. During ATI, HIV-1 pVL was monitored weekly and ART was resumed if pVL >100,000 copies/mL or remained >10,000 for 8 consecutive weeks. A specifically designed 19-item questionnaire (3 dimensions: Concerns, Expectations, Satisfaction) was administered at ATI-start and ATI-end. Fisher’s exact test was used to compare changes, with analyses stratified by clinical trial and ATI duration (≤12 vs >12 weeks).
Results
71 participants completed the ATI-start and 59 the ATI-end questionnaires. Risk of HIV onward transmission was the most reported concern at ATI-start (51%), without significant changes at ATI-end (47%). Less interest in sex and reduced intention to engage in sexual activity during ATI were reported at both timepoints, particularly among BCN03 participants. Concerns about viral recrudescence leading to HIV-related symptoms and potential immune deterioration significantly decreased from ATI-start to ATI-end (43% to 10%, p<0.001; 43% to 17%, p=0.002). Notably, 90% participants felt prepared to interrupt ART and only 14% expressed fear about stopping ART. At ATI-end, <15% participants reported any negative impact of ATI on quality of life. Acceptance of weekly monitoring remained high regardless of ATI duration (95%). In both trials, 95% considered the information provided by investigators to be sufficient and 86% indicated willingness to participate in future HIV cure trials.
Conclusions
Overall, participant experiences with ATI in the AELIX-002 and BCN03 trials were favorable. Expectations improved during the ATI and satisfaction levels remained high. Potential HIV transmission was the most frequent concern in both studies and did not diminish after ATI. Time since HIV diagnosis may influence impact of ATI on sexual activity. These findings highlight the importance of incorporating systematic psychosocial assessments into HIV cure studies that include ATI in order to identify individuals who may require tailored support.