Evaluation of Counseling for Partner Notification

Sexually Transmitted Infections Clinical Trial

— PN  

Official title:

Evaluation of Partner Notification for Sexually Transmitted Infections in Bangladesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060839
• Other study ID #: 2006-001
• Secondary ID: BC#03111459
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 1, 2010
• Last updated: February 1, 2010
• Start date: April 2006
• Est. completion date: December 2007

Study information

• Verified date: February 2010
• Source: International Centre for Diarrhoeal Disease Research, Bangladesh
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bangladesh: Ethical Review Committee
• Study type: Interventional

Clinical Trial Summary

• In the formative stage of the project, we have investigated through qualitative and quantitative studies to identify a potential intervention to promote partner referral for sexually transmitted patients in Bangladesh.

• We conducted a quasi-randomised trial to evaluate if single session counseling is effective in improving partner referral for patients with sexually transmitted infection.

Description:

The study was a quasi-randomized trial, alternating partner referral counselling and standard of care approach for each subsequent patient. First patients was randomly assigned by the project research physician in each clinic then alternative patients allocation was maintained by the study interviewers assigned in each clinic. For index cases assigned to the counselling arm, a same sex counselor conducted 10-15 minutes individualized sessions. Counselors were specifically trained to deliver partner referral counselling focusing on five issues related to STI prevention and transmission: (1) risk of re-infection if partners are not treated concurrently; (2) risk of developing complications; (3) risk of further spread of infection in the community; (4) the asymptomatic nature of infection; and (5) social obligations and personal coping with an STI. Patients in the standard care group received the existing services in the respective clinics, which included clinical consultation, prescription for medication but there was no partner referral counselling per se. In the public clinics, both the counselling and non-counselling group of clients received free medications, while in the NGO clinics they received subsidized fee medications. Both groups also received standard, pre-tested anonymous partner referral cards along with a short briefing by the interviewers that index clients need to hand over this card to their partner(s) to bring them to the respective clinics for assessment of STI status. Partner referral cards were used to follow-up partner referral by tracking the patient identification number and disease code of cards provided by referred patients. In addition, referral cards were useful for the partners to locate the study clinic, to be entitled to free or subsidized medication, and to distinguish the partners from index cases coming to the clinics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1339
• Est. completion date: December 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Each newly diagnosed STI patients

• Age > 18 years

• Who had a sexual exposure in last three months

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Sexually Transmitted Diseases
• Sexually Transmitted Infections

Intervention

Behavioral:
• Single session counseling
For index cases assigned to the counselling arm, a same sex counselor conducted 10-15 minutes individualized sessions. Counselors were specifically trained to deliver partner referral counselling focusing on five issues related to STI prevention and transmission: (1) risk of re-infection if partners are not treated concurrently; (2) risk of developing complications; (3) risk of further spread of infection in the community; (4) the asymptomatic nature of infection; and (5) social obligations and personal coping with an STI.

Locations

Country	Name	City	State
Bangladesh	Dhaka Medical College Hospital, Skin VD out patient clinic	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
International Centre for Diarrhoeal Disease Research, Bangladesh

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of index cases, who referred one or more partner/s to the study clinics within one month of interview.		within one month of interview	No