Evaluation of Counseling for Partner Notification

Phase 1

Completed

• Conditions: Sexually Transmitted Infections
• Interventions: Behavioral: Single session counseling

• Registration Number: NCT01060839
• Lead Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-04
• Primary Completion: 2007-08
• Study Completion: 2007-12
• Status Verified: 2010-02
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-01
• Last Update Submitted: 2010-02-01
• Study First Posted: 2010-02-02
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1339

Inclusion Criteria

• Each newly diagnosed STI patients
• Age > 18 years
• Who had a sexual exposure in last three months

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single session counseling	Single session counseling	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dhaka Medical College Hospital, Skin VD out patient clinic; 🇧🇩 Dhaka, Bangladesh