Booklet for knowledge and prevention of HIV mother-to-child transmission: a pilot study of a randomized clinical trial*

{"Background": "The detection rate of HIV among pregnant women has increased by 38.1% over the last decade. Vertical transmission of HIV (HIV-VT) can be reduced to less than 2% with proper interventions throughout pregnancy, delivery, and postpartum. However, gaps persist in pregnant women's understanding of HIV, transmission routes, testing, and antiretroviral therapy (ART) use. Educational technologies such as booklets may support behavioral change and empower women to prevent HIV-VT. The booklet \"How to prevent mother-to-child HIV transmission? Be up on it!\" was previously developed and validated to address this need.", "Methods": "This pilot RCT was conducted between January 2017 and May 2018 in three public maternity hospitals in Fortaleza-CE, Brazil. Of 144 pregnant women screened, 104 were eligible. After block randomization using computer-generated sequences (http://www.randomizer.org), 52 were allocated to each arm. The control group received usual verbal counseling from health professionals, while the intervention group additionally received a 15-20 minute individual educational session using the booklet. Knowledge was assessed using a validated instrument (0-16 points) covering HIV-VT prevention during pregnancy (0-7 points), delivery (0-3 points), and postpartum (0-5 points). Evaluations occurred at baseline, 7-15 days (telephone), and 30 days postpartum. Final sample comprised 45 women (24 IG, 21 CG) due to 56.7% loss to follow-up. Analyses included intergroup and intragroup comparisons using Student's t tests, with intention-to-treat analysis as sensitivity. The study was registered on ReBEC (UTN: U1111-1191-9954).", "Key Results": "Sociodemographic characteristics were homogeneous between groups except for race (p = 0.030). Mean age was 26.91 years (SD \u00b1 6.09), mean education 9.14 years (SD \u00b1 2.47), and median income BRL 937.00. In intergroup analysis, there was no significant difference in mean knowledge scores (short-term p = 0.473; long-term p = 0.151), confirmed by intention-to-treat analysis (baseline p = 0.374; 7-15 days p = 0.837; 30 days postpartum p = 0.468). However, in intragroup analysis within the intervention group, knowledge improved significantly from baseline (M = 4.19, SD = 2.14) to 7-15 days (M = 5.27, SD = 1.99; p = 0.002), and from baseline (M = 4.71, SD = 2.35) to 30 days postpartum (M = 5.58, SD = 1.89; p = 0.033). The control group showed no significant intragroup improvement (baseline \u00d7 7-15 days p = 0.051; baseline \u00d7 30 days p = 0.277). Specific knowledge items improved in IG, including \"use of HIV medication during pregnancy\" (71.70% to 91.89%; p = 0.004), \"use of HIV medication during childbirth\" (24.53% to 66.67%; p = 0.001), and postpartum care awareness (79.25% to 94.59%; p = 0.008). Knowledge gaps remained regarding prenatal consultations, examinations, nutrition, and lifestyle.", "Clinical Implications": "The booklet demonstrated promise as an adjunct educational tool within the intervention group, particularly improving understanding of ART use during pregnancy, delivery, and postpartum. However, the lack of intergroup difference combined with substantial 56.7% attrition (consistent with similar telephone-based trials reporting 35.7-56.9% losses) limits definitive conclusions. Limitations include stigma affecting participation, telephone-based follow-up challenges, potential cross-contamination between groups, and uncontrolled confounders such as socioeconomic determinants of learning. A larger, adequately powered RCT with in-person follow-up, reduced attrition strategies, and researchers embedded within prenatal services is needed to establish the booklet's effectiveness. Despite limitations, this pioneering study addresses an important gap in printed educational materials for HIV-VT prevention and suggests booklets may serve as supplementary informational support for pregnant women living with HIV."}