NCT02416648

Brief Summary

The purpose of this study was to determine the effectiveness of a clinician client centered counseling on knowledge on HIV transmission and prevention, attitudes towards HIV/AIDS, and sexual behaviors of adult HIV patients enrolled in care in Yola, Nigeria.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
386

participants targeted

Target at P50-P75 for not_applicable hiv

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable hiv

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

March 23, 2015

Last Update Submit

April 14, 2015

Conditions

Keywords

Adult HIV patientsKnowledgeAttitudesSexual behaviors

Outcome Measures

Primary Outcomes (5)

  • Knowledge on HIV prevention and transmission

    Knowledge on HIV prevention and transmission was assessed in section 2 of the questionnaire. This section had a total of 17 statements and answers with options of 'yes', 'no' and 'don't know'. A correct response had a score of 1 and an incorrect response a score of 0. Mean knowledge scores were determined at baseline, 2 months and 6 months and comparison made among the 3 groups.

    Change from baseline knowledge on HIV prevention and transmission at 2 months and at 6 months

  • Attitude towards HIV/AIDS

    Attitudes towards HIV/AIDS was assessed in section 3 of the questionnaire. This section consisted of 5 statements to address patient's attitude towards HIV/AIDS. Answer options to these questions were from a 5 point Likert scale ranging from strongly agree, agree, don't know, disagree and strongly disagree. A score of '1' was assigned to 'strongly disagree', a score of '2' was assigned to 'disagree', a score of '3' was assigned to 'don't know', a score of '4' was assigned to 'agree' and a score of '5' was assigned to 'strongly agree' Total score possible for attitude range from 5 to 25. On the basis of summated scores respondents were divided into high or low attitude using the 50 percentile as cut off. Attitude scores were determine at baseline, 2 months and 6 months and comparison made among the 3 groups.

    Change from baseline attitudes towards HIV/AIDS at 2 months and at 6 months

  • Frequency of condom use

    Frequency of condom use was assessed in section 4 of the questionnaire. The proportions of self reported protected sexual activity (vaginal, anal and oral) out of all sexual activity in the preceding 30 days before the interviews were determined for each respondent. These proportions were determined at baseline, 2 months and 6 months and represented the condom use scores. Median condom use score were determined at baseline, 2 months and 6 months and comparison made among the 3 groups

    Change form baseline frequency of condom use during sexual activity at 2 months and at 6 months

  • Multiple sexual partners

    Self reported number of sexual partners of respondents was assessed in section 4 of the questionnaire. A score of '1' was given to each number of sexual partner reported by respondents in the preceding 30 days of the interview.The means of this scores were determined at baseline, 2 months and 6 months and comparison made among the 3 groups.

    Change from baseline number of multiple sexual partners at 2 months and at 6 months

  • Status disclosure

    HIV status disclosure to spouses/sex partners was assessed in section 5 of the questionnaire. Self reported number of spouses/sex partners the respondents had disclosed their HIV status too was determined at baseline, 2 months and 6 months, A score of '1' was given to each spouse/sex partner who was aware of the respondents HIV status at the time of the interviews at baseline, 2 months and 6 months. This represented the status disclosure score. The means of these status disclosure scores were determined at baseline, 2 months and 6 months and comparison made among the 3 groups.

    Change from baseline HIV status disclosure to spouse or sex partner at 2 months and at 6 months

Study Arms (3)

CCC Counseling; baseline and 2 months

EXPERIMENTAL

Intervention group 1 received 2 CCC Counseling sessions; at baseline and at 2 months. The intervention was a 10 to 15 minute clinic based one on one counseling session between a clinician (counselor) and a HIV positive adult patient (client). Areas covered during the brief counseling included; HIV transmission and prevention, healthy sexual practices, condom use, reduction in multiple sexual partners, beneficial disclosure, and individual risk assessment and reduction strategies.

Behavioral: Clinician Client Centered (CCC) Counseling

CCC Counseling; baseline

EXPERIMENTAL

Intervention group 2 received a session CCC Counseling session at baseline only. The intervention was a 10 to 15 minute clinic based one on one counseling session between a clinician (counselor) and a HIV positive adult patient (client). Areas covered during the brief counseling included; HIV transmission and prevention, healthy sexual practices, condom use, reduction in multiple sexual partners, beneficial disclosure, and individual risk assessment and reduction strategies.

Behavioral: Clinician Client Centered (CCC) Counseling

Routine care

NO INTERVENTION

The control group received routine clinic care.

Interventions

Counseling sessions were interactive allowing for listening, questions and answers. They were cultural sensitive and also consider issues related to gender and age. Areas covered during the brief counseling included; HIV transmission and prevention, healthy sexual practices, condom use, reduction in multiple sexual partners, beneficial disclosure, and individual risk assessment and reduction strategies. Clinicians evaluated patients' readiness to change risky or maintain safer behaviors. They also assisted the patient to negotiate an individually tailored behavior change or maintenance plan of action.

CCC Counseling; baselineCCC Counseling; baseline and 2 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all persons diagnosed with HIV ≥ 18years of age presenting to the 4 comprehensive ART clinics in Yola

You may not qualify if:

  • Patients excluded from this study were:
  • those patients who declined consent
  • adult HIV positive patients diagnosed with mental illnesses rendering them unfit to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

BehaviorCoitus

Interventions

Counseling

Condition Hierarchy (Ancestors)

Sexual Behavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Olutayo F Martins, MBBS, MPH

    Department of Community Medicine, Faculty of Medicine and Health Sciences, Universiti Putra Malaysia, Malaysia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 23, 2015

First Posted

April 15, 2015

Study Start

January 1, 2014

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 15, 2015

Record last verified: 2015-04