In China, more than 30% of patients have not initiated treatment within 30 days of HIV diagnosis. Delayed initiation has a detrimental influence on disease outcomes and increases HIV transmission. The study aims to evaluate the effectiveness of a nurse-led antiretroviral therapy initiation nudging intervention for people newly diagnosed with HIV in China to find the optimal intervention implementation strategy.
A Hybrid Type II sequential multiple assignment randomized trial will be conducted at four Centers for Disease Control and Prevention in Hunan, China. This study will recruit 447 people newly diagnosed with HIV aged ≥18 years and randomly assign them into two intervention groups and one control group. On top of the regular counselling services and referrals, intervention groups will receive a 4-week, 2-phase intervention based on the dual-system theory and the nudge theory. The control group will follow the currently recommended referral procedures. The primary outcomes are whether treatment is initiated, as well as the length of time it takes. The study outcomes will be measured at the baseline, day 15, day 30, week 12, week 24 and week 48. Generalized estimating equations and survival analysis will be used to compare effectiveness and explore factors associated with antiretroviral therapy initiation. Both qualitative and quantitative information will be collected to assess implementation outcomes.
Existing strategies mostly target institutional-level factors, with little consideration given to patients' decision-making. To close this gap, we aim to develop an effective theory-driven nudging strategy to improve early ART initiation.
This nurse-led study will help to prevent delayed initiation by employing implementation science strategies for people newly diagnosed with HIV. This study contributes to the United Nations' objective of ending the AIDS pandemic by 2030.
Chinese Clinical Trial Registry ChiCTR2300070140. The trial was prospectively registered before the first participant was recruited.
The nudging intervention was finalized through the Nominal Group Technique where we invited five experts in the related field and five people living with HIV to participate.
In the era of ‘Undetectable = Untransmittable’ (U=U), reductions in condom use and increases in casual partnerships may contribute to elevated risks of coinfection with other sexually transmitted infections (STIs) and HIV super-infections among men living with HIV. These trends may reflect a shift in personal attitudes towards sexual behaviour and HIV risk, yet their influence on actual behaviours remains unclear.
To investigate how changes in personal attitudes and safe sex self-efficacy influence sexual decision-making.
Two-wave longitudinal study design.
We conducted a 3-month longitudinal study from March to December 2023 among HIV-positive men (≥ 18 years) initiating ART in Changsha, China. Cross-lagged panel analysis and half-longitudinal mediation analysis were used to examine how changes in personal attitudes influenced sexual behaviours.
427 men living with HIV were included at baseline, and 301 completed the follow-up survey. Sexual behaviours were associated with personal attitudes, namely safe sex fatigue, viral load/transmission beliefs, and sexual sensation seeking. More positive personal attitudes in these domains at baseline predicted lower safe sex self-efficacy over 3 months, while reduced baseline self-efficacy increased the likelihood of engaging in condomless sex and/or multiple sexual partners. All three personal attitude domains had significant indirect effects on sexual behaviours via safe sex self-efficacy.
In the era of U=U, the changed personal attitudes among men living with HIV may lead to the increased likelihood of engaging in condomless sex and/or having multiple sexual partners, and safe sex self-efficacy serves as a mediator in this relationship.
This study highlights the potential influence of attitudinal changes on sexual behaviours among men living with HIV in the ‘U=U’ era. Findings provide valuable evidence for developing more targeted interventions that address not only behavioural outcomes but also underlying personal attitudes.
No patient or public contribution.