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NCT06163859
Female Community Health Volunteers Led Hypertension Prevention and Control in Nepal
NA trial testing Intervention Group in Hypertension in 520 participants. Completed in 1 May 2025.
16 March 2025
Quick facts
| Lead sponsor | Kathmandu University School of Medical Sciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 520 |
| Start date | 5 January 2024 |
| Primary completion | 16 March 2025 |
| Estimated completion | 1 May 2025 |
| Sites | 1 location across Nepal |
Drugs / interventions tested
- Intervention Group — full drug profile →
Conditions studied
- Hypertension — all drugs for Hypertension →
Sponsor
Kathmandu University School of Medical Sciences
Who can join
Adults 30 to 75, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Brief Summary Hypertension is a major public health problem in Nepal, with substantial gaps in awareness, treatment, and control, particularly in rural and semi-urban settings. Nepal has adopted the WHO Package of Essential Non-Communicable Diseases (PEN) to strengthen facility-based hypertension care; however, persistent community- and system-level barriers limit its effectiveness. This study evaluates a Female Community Health Volunteer (FCHV)-led, community-based hypertension prevention and control intervention in Namobuddha Municipality, Kavrepalanchowk District, Nepal. The study uses a hybrid type II effectiveness-implementation cluster randomized controlled trial design to assess both implementation outcomes and clinical effectiveness. Twelve public primary healthcare facilities are randomized (1:1) to intervention or routine care. Implementation outcomes are assessed using the RE-AIM framework (Reach, Effectiveness, Adoption, and Implementation). The primary effectiveness outcome is change in mean systolic blood pressure at three months. Secondary outcomes include diastolic blood pressure, hypertension control status, hypertension knowledge, dietary behavior, medication adherence, and body mass index. The intervention mobilizes trained FCHVs to deliver group-based blood pressure monitoring, structured health education, lifestyle counseling, medication adherence support, and referral linkages to primary healthcare facilities.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06163859
- Europe PMC full search
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Currently open trials in the same condition.
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Other Kathmandu University School of Medical Sciences trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06163859 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kathmandu University School of Medical Sciences
- Last refreshed: 13 January 2026
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