Clinical trial Recruiting at 1 site Interventional Ages 25 to 49 Women only

Comparing two treatments for cervical cancer risk reduction in women living with HIV in Mozambique

Official title: A Randomized Clinical Trial to Assess the Effectiveness of Thermal Ablation Versus Loop Electrosurgical Excision Procedure for Cervical Cancer Risk Reduction in Women Living With Human Immunodeficiency Virus in Mozambique

Run by Instituto Nacional de Saúde, Mozambique · NCT06326294 · Data updated 2026-11-12

This study is testing two different treatments for pre-cancerous cervical lesions in women living with HIV in Mozambique to see which one works better in getting rid of high-risk HPV.

More HIV Infections trials

Quick facts

Study typeInterventional
Ages25 Years to 49 Years
SexWomen only
Enrollment4844 (estimated)
SponsorInstituto Nacional de Saúde, Mozambique
Government
Locations1 site (Maputo)
StatusRecruiting
StartedApril 17, 2024
Main results expectedSeptember 2027
Study endsDecember 2027
Registry record updatedMay 22, 2024
Trial IDNCT06326294 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are women aged 25-49 years who are confirmed to be HIV positive.

Probably not a fit

Patients who are currently pregnant, have had a hysterectomy, or have a history of cervical cancer will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to compare the effectiveness of thermal ablation (TA) and loop electrosurgical excision procedure (LEEP) in treating pre-cancerous cervical lesions and HPV infections in women living with HIV (WLWH) in Mozambique. It will assess the effectiveness of both treatments in eradicating high-risk HPV and managing biopsy-confirmed CIN 2/3. Additionally, the study will identify factors that contribute to treatment failure and develop a predictive tool to help tailor alternative treatments for patients at risk of failure. The findings will provide local evidence to inform health policy and improve adherence to cervical cancer prevention strategies.

Why it matters

Potential benefit: If successful, this study could lead to more effective and accessible treatment options for cervical cancer prevention in women living with HIV.

How similar studies have gone: Other studies have shown success with similar treatment comparisons, but this specific approach in the context of WLWH in Mozambique is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* ages 25-49 years;
* confirmed HIV infection;
* physically and mentally willing and able to participate in the study, and provide informed consent.

Exclusion Criteria:

* currently pregnant or \<6 weeks post-partum;
* had a hysterectomy and no longer have a cervix;
* a history of cervical cancer or treatment for cervical abnormalities; and
* any medical, psychiatric, or other condition that would interfere with protocol adherence, assessment of safety, and/or ability/competence to provide informed consent.

Where it's running

  • INSMozambique
    Maputo, Mozambique
    Recruiting

Study contacts

  • Principal investigator: Edna Viegas, MD, PhD — Instituto Nacional de Saúde, Mozambique
  • Study coordinator: Edna Viegas, MD, PhD
  • Email: edna.viegas@ins.gov.mz
  • Phone: +258823060500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.