Evaluation of Counseling for Partner Notification (PN)

International Centre for Diarrhoeal Disease Research (icddr,b)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Sexually Transmitted Infections

Treatments: Behavioral: Single session counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT01060839

2006-001

BC#03111459 (Other Identifier)

Details and patient eligibility

About

• 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.

Full 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.

Enrollment: 1,339 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,339 participants in 2 patient groups

Single session counseling

Experimental group

Treatment:

Behavioral: Single session counseling

Standard of care

No Intervention group