Evaluation of Counseling for Partner Notification (PN)
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Purpose
- 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 | Intervention | Phase |
|---|---|---|
|
Sexually Transmitted Infections |
Behavioral: Single session counseling |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Evaluation of Partner Notification for Sexually Transmitted Infections in Bangladesh |
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 1339 |
| Study Start Date: | April 2006 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Each newly diagnosed STI patients
- Age > 18 years
- Who had a sexual exposure in last three months
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01060839
| Bangladesh | |
| Dhaka Medical College Hospital, Skin VD out patient clinic | |
| Dhaka, Bangladesh | |
| Principal Investigator: | Nazmul Alam, DrPH | International Centre for Diarrhoeal Disease Resaerch, Bangladesh |
More Information
No publications provided
| 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 |
| Study First Received: | February 1, 2010 |
| Last Updated: | February 1, 2010 |
| Health Authority: | Bangladesh: Ethical Review Committee |
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
|
counseling |
Additional relevant MeSH terms:
|
Sexually Transmitted Diseases Genital Diseases, Female Genital Diseases, Male Infection Virus Diseases |
ClinicalTrials.gov processed this record on March 01, 2015