Evaluation of Counseling for Partner Notification (PN)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Sexually Transmitted Infections	Behavioral: Single session counseling	Phase 1; Phase 2

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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1339 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Evaluation of Partner Notification for Sexually Transmitted Infections in Bangladesh
Study Start Date :	April 2006
Actual Primary Completion Date :	August 2007
Actual Study Completion Date :	December 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Single session counseling	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.; Other Name: counseling
No Intervention: Standard of care

Outcome Measures

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Primary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Bangladesh
Dhaka Medical College Hospital, Skin VD out patient clinic
Dhaka, Bangladesh

Sponsors and Collaborators

International Centre for Diarrhoeal Disease Research, Bangladesh

Investigators

Principal Investigator:	Nazmul Alam, DrPH	International Centre for Diarrhoeal Disease Resaerch, Bangladesh

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Nazmul Alam, Senior Research Investigator, International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:	NCT01060839 History of Changes
Other Study ID Numbers:	2006-001; BC#03111459 ( Other Identifier: ICDDR,B )
First Posted:	February 2, 2010
Last Update Posted:	February 2, 2010
Last Verified:	February 2010

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

counseling

Additional relevant MeSH terms:

Infection; Sexually Transmitted Diseases; Virus Diseases; Genital Diseases, Male; Genital Diseases, Female