Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive Women Living With HIV in C1001P-CS7 Zimbabwe
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 25 and 49 years old?
Where in Zimbabwe
- Harare · University of Zimbabwe, Centre for ResearchTaking people
The registry text, word for word
Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living With HIV
Cervical cancer disproportionately affects women in low- and middle-income countries (LMICs), particularly women living with HIV (WLWH) who have a 6-fold increased risk of cervical cancer compared to women in the general population. While thermal ablation (TA) is a WHO- recommended treatment for cervical precancerous lesions, its efficacy can be suboptimal in WLWH. We will also conduct a feasibility treatment cohort study of up to 300 Zimbabwean WLWH to provide evidence for a larger treatment effectiveness study. The proposed study will evaluate the feasibility, acceptability, and safety of a two-probe TA technique (endocervical and ectocervical probes) and whether this approach improves treatment outcomes among WLWH compared to one (ectocervical) probe. This innovation has the potential to significantly enhance cervical cancer prevention efforts in high-burden settings and to contribute towards achieving the 90-70-90 goals of the World Health Organization's (WHO) strategy for accelerated elimination of cervical cancer as a public health problem by 2030.
Inclusion: 25-49 years old; Living with HIV; Intact cervix; Willing to return to facility at 6 months; Willing and able to provide informed consent; Positive hrHPV or VIA test within 3 months of enrollment; Type 1 transformation zone (TZ1); Thermal ablation eligible.
Exclusion: Prior diagnosis of cervical cancer; Currently receiving treatment for any cancer; Screened for cervical cancer outside of study in last 6 months; A history of treatment for cervical precancer; Individual has a condition that the Clinical Site PI believes will interfere with or affect the conduct, results, or completion of the clinical study; Individual has a condition that the Clinical Site PI considers creates an unacceptable risk to the individual if enrolled; Currently pregnant or less than 6 weeks postpartum; Total hysterectomy.