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Evaluation of Counseling for Partner Notification (PN)

Primary Purpose

Sexually Transmitted Infections

Status
Completed
Phase
Phase 1
Locations
Bangladesh
Study Type
Interventional
Intervention
Single session counseling
Sponsored by
International Centre for Diarrhoeal Disease Research, Bangladesh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sexually Transmitted Infections focused on measuring counseling

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Sites / Locations

  • Dhaka Medical College Hospital, Skin VD out patient clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Single session counseling

Standard of care

Arm Description

Outcomes

Primary Outcome Measures

Proportion of index cases, who referred one or more partner/s to the study clinics within one month of interview.

Secondary Outcome Measures

Full Information

First Posted
February 1, 2010
Last Updated
February 1, 2010
Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh
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1. Study Identification

Unique Protocol Identification Number
NCT01060839
Brief Title
Evaluation of Counseling for Partner Notification
Acronym
PN
Official Title
Evaluation of Partner Notification for Sexually Transmitted Infections in Bangladesh
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
International Centre for Diarrhoeal Disease Research, Bangladesh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Transmitted Infections
Keywords
counseling

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1339 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single session counseling
Arm Type
Experimental
Arm Title
Standard of care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Single session counseling
Other Intervention Name(s)
counseling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of index cases, who referred one or more partner/s to the study clinics within one month of interview.
Time Frame
within one month of interview

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Each newly diagnosed STI patients Age > 18 years Who had a sexual exposure in last three months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazmul Alam, DrPH
Organizational Affiliation
International Centre for Diarrhoeal Disease Resaerch, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dhaka Medical College Hospital, Skin VD out patient clinic
City
Dhaka
Country
Bangladesh

12. IPD Sharing Statement

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Evaluation of Counseling for Partner Notification

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