ArticlemedRxiv : the preprint server for health sciences2026
Efficacy of Combination Treatment for Cervical Precancer Among Women Living with HIV in South Africa: Secondary Outcomes from the ACT 2 Randomized Controlled Trial.
Article in medRxiv : the preprint server for health sciences, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05413811 (Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV), which is not on this map. Not yet cited in PubMed.
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Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living With HIV
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Abstract
Objective: We report secondary histologic and high-risk HPV (hrHPV) outcomes from the Acceptability and Feasibility of Combination Treatment for Cervical Precancer Among South African Women Living with HIV (ACT 2) Trial. Methods: We conducted a double-blind Phase 2b feasibility trial of loop electrosurgical excision procedure (LEEP) combined with adjuvant intravaginal 5-fluorouracil (5FU) cream. Women living with HIV (WLWH) and cervical intraepithelial neoplasia (CIN) 2/3 underwent LEEP and were randomly assigned (1:1) to receive 8 doses of 5FU or placebo cream. Our secondary outcomes were (a) regression of cervical disease and (b) clearance of hrHPV. Results: From March 2023 to January 2025, 180 participants underwent LEEP and were randomized to 5FU or placebo cream. Median age was 41 years (IQR: 35-45), 29% had HPV16, 18% had HPV18/45; 99% of women were virologically suppressed (<200 copies/mL) and median CD4 count was 636 cells/uL (IQR: 376-873). 172 participants (95.6%) completed follow-up. At week 24, 96.3% (78/81) in the 5FU group and 82.0% (73/89) in the placebo group regressed to CIN1 or normal histology (PD 14.3%, CI 5.3%, 23.3%). Among participants with positive LEEP margins at week 0, 88.0% (22/25) in the 5FU versus 61.3% (19/31) in the placebo group regressed to CIN1 or normal (PD 26.7%, CI 5.4%, 48.1%). Genotype-specific hrHPV clearance was similar in both groups (5FU: 58.0%, 40/69; Placebo: 53.8%, 43/80; PD 4.2%, CI -11.7%, 20.2%). Conclusion: Clinical outcomes from our Phase 2b trial demonstrates that intravaginal 5FU post-LEEP may be a beneficial adjuvant treatment for CIN2/3. Clinical Trial Registration: NCT05413811.
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