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Feasibility Study for Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living with HIV

Feasibility Study for Expanded Use of Thermal Ablation (EXCEL Cohort) and Prophylactic Use of Two Probes (PRO Cohort) for Cervical Cancer Prevention in Women Living with HIV

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
PACTR
Registry ID
PACTR202605498193640
Enrollment
800
Registered
2026-05-29
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV/AIDS

Interventions

TA Technique
Standard TA Technique

Sponsors

National Cancer Institute
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Study population Inclusion criteria 1. 25-49 years old 2. Living with HIV Inclusion criteria specific to the feasibility study 1. Intact cervix 2. Willing to return to facility at 6 months 3. Willing and able to provide informed consent 4. Positive hrHPV or VIA test within 3 months of enrollment

Exclusion criteria

Exclusion criteria: Exclusion criteria specific to the feasibility study 1. Screened for cervical cancer in last 6 months 2. Currently pregnant or less than 6 weeks postpartum 3. Prior diagnosis of cervical cancer 4. A history of treatment for cervical precancer 5. Total hysterectomy 6. Currently receiving treatment for any cancer

Design outcomes

Primary

MeasureTime frame
1. To evaluate the feasibility, acceptability, and safety of implementing a two-probe TA technique among WLWH at the CASCADE Network CS9 site and collaborating health facilities. 2. To augment ongoing quality control efforts of clinical procedures in the screening-to-treatment cascade that support the implementation of future clinical trials for cervical cancer prevention.

Secondary

MeasureTime frame
• Difference in the proportion of women with hrHPV persistence. • Difference in the proportion of women requiring further treatment • Comparative patient-reported acceptability scores • Comparative frequency and severity of adverse events

Countries

South Africa

Contacts

Public ContactNqobile;Bongekile Myeni;Zuma

CAPRISA;CAPRISA

nqobile.myeni@caprisa.org;bongekile.zuma@caprisa.org0712420488;0653562631

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026