Women's Global Health Imperative, RTI International, Berkeley, CA.
MRC/Wits Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
J Acquir Immune Defic Syndr. 2023 May 1;93(1):1-6. doi: 10.1097/QAI.0000000000003161.
Research trial participation may influence health outcomes regardless of the intervention assigned, but is often not assessed.
We investigated how participation in an HIV prevention trial (the HIV Prevention Trials Network (HPTN) 068 study) affected health outcomes 4 years after the study in adolescent girls and young women in South Africa beyond effects of the tested intervention.
We developed an analytical cohort that included the HIV Prevention 068 trial (HPTN 068) trial participants from the Agincourt Health and Demographic Surveillance System and resembled HPTN 068 trial enrollees (aged 13-20 years and in grades 8-11 in 2011) using inverse probability of treatment weights. We estimated risk differences for the association between trial participation and education and early parity (age <20 years) in 2019, after accounting for differences at baseline between the trial participants and nonparticipants.
There were 3442 young women enrolled in grades 8-11 in 2011; 1669 were in the HPTN 068 trial. Trial participants were more likely to have completed secondary school by 2019 (adjusted RD (aRD) 5.0%, 95% confidence interval (CI) 2.2%, 7.9%; 82.3% in trial participants vs. 77.2% in nonparticipants). Trial participants had similar risk of parity before age 20 compared with nontrial participants (aRD 2.3%, 95% CI: -0.8%, 5.5%).
Trial participation did not seem to influence early parity, but did increase educational attainment. Our results are compatible with an explanation of Hawthorne effects from trial participation on schooling behaviors that were small, but observable even 4 years after the end of the trial.
研究试验的参与可能会影响健康结果，无论分配的干预措施如何，但通常不会进行评估。
我们研究了在南非的青少年女孩和年轻妇女中，参与艾滋病毒预防试验（艾滋病毒预防试验网络（HPTN）068 研究）如何在研究结束后 4 年内影响健康结果，超出了所测试干预措施的影响。
我们开发了一个分析队列，其中包括来自 Agincourt 健康和人口监测系统的艾滋病毒预防 068 试验（HPTN 068）试验参与者，并使用逆概率治疗权重使其类似于 HPTN 068 试验的参与者（年龄在 13-20 岁，2011 年在 8-11 年级）。我们估计了试验参与与教育和早育（年龄<20 岁）之间的关联风险差异，同时考虑了试验参与者和非参与者之间的基线差异。
在 2011 年有 3442 名年轻女性在 8-11 年级注册；其中 1669 人参加了 HPTN 068 试验。到 2019 年，试验参与者更有可能完成中学学业（调整后的差异（aRD）5.0%，95%置信区间（CI）2.2%，7.9%；试验参与者为 82.3%，而非参与者为 77.2%）。与非试验参与者相比，试验参与者在 20 岁之前生育的风险相似（aRD 2.3%，95%CI：-0.8%，5.5%）。
试验参与似乎并没有影响早育，但确实增加了教育程度。我们的结果与从试验参与中观察到的对学校行为的霍桑效应的解释一致，这种效应很小，但即使在试验结束后 4 年仍能观察到。
