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AzTrials

HIVNCT02416648

Effectiveness of Clinician Client Centered Counseling on Sexual Behaviors of Antiretroviral Therapy Patients in Nigeria

A study testing Clinician Client Centered (CCC) Counseling in people with HIV, run by Universiti Putra Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV
What is being tested?
Clinician Client Centered (CCC) Counseling
Could I receive a placebo?
No, everyone receives an active treatment
How many people
386 participants
Where
No sites listed yet
Study dates
Jan 2014to Sep 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Criteria for inclusion into this study included:
  • all persons diagnosed with HIV ≥ 18years of age presenting to the 4 comprehensive ART clinics in Yola

Who cannot join

  • 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

About this study

Official title: Effectiveness of Clinician Client Centered Counseling on Knowledge, Attitudes and Sexual Behaviors of Antiretroviral Therapy Patients in Yola, Nigeria

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.

Read the detailed description

This study was a 3 arm randomized single blind clinical trial involving 386 randomly selected and allocated adult HIV patients who were enrolled into Antiretroviral Therapy (ART) care at all 4 comprehensive ART sites in Yola. These comprehensive sites were the; Federal Medical Center (FMC) Yola, State Specialist Hospital Yola (SSHY), St Francis Hospital Jambutu and Adamawa Hospital. The trail took place from January to September 2014. A Clinician Client Centered training module was developed based on the Information Behavior and Motivation (IBM) Model. 9 Clinicians involved in ART care were trained with this module to deliver a 10 to 15 minutes clinic based intervention (Clinician Client Centered (CCC) counseling). Intervention group 1 received 2 counseling sessions; at baseline then at 2 months. Intervention group 2 received 1 counseling session at baseline only and the control group received routine care. An interviewer administered validated and reliable structured questionnaire was used for data collection. The questionnaire consisted of 5 sections; Section 1 consisted of a code number and socio-demographic variables. Section 2 consisted of questions on the knowledge of HIV transmission and prevention. This section has a total of 17 statements and answers that had the options of 'yes', 'no' and 'don't know'. Section 3 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. 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. Section 4; addressed sexual behavior patterns (condom use and number of sexual partners)questions in this section addressed; recent sexual activity in last 30 days preceding the survey, type of sexual relationship (monogamous or polygamous), condom use, gender of sexual partner and type of sexual practice. Section 5 addressed issues of status disclosure. Questions were directed at number of spouse/sexual partner who were aware of the respondents' HIV status. It also determine number of other persons HIV status had been disclosed and the effects of such disclosure. Data was collected at baseline, 2 months and 6 months.

Questionnaires were manually validated for errors and data analyzed using SPSS (Statistical Package for Social Sciences) version 22. All data with interval and ratio scale were explored using graphical methods (histogram with normal distribution curve and whisker box plot) to exam for normality. Parametric statistical test were used for normally distributed data and non parametric equivalent used were normality assumption was violated. For descriptive statistics measures of central tendency and dispersion were used for continuous data. Percentages were used to describe categorical data. The median and interquartile ranges (IQR) were used when the assumption of normality was violated.

Inferential statistics was used to determine homogeneity of respondent's socio-demographic variable between intervention group 1, intervention group 2 and control group. Data transformation was performed on data which were not normally distributed. Data transformation performed on not normally distributed condom use scores with both log10 and square root transformation was unsuccessful. One way ANOVA was used to compare mean differences of scores of log HIV knowledge, log attitudes scores towards HIV/AIDS and HIV status disclosure scores among the two intervention groups and the control group at baseline, 2 months and at 6 months. Kruskal Wallis ANOVA was used to compare median condom use scores among the 3 study groups at baseline, 2 months and 6 months. Spearman's correlation coefficient was used to investigate relationships between HIV knowledge, attitudes towards HIV and sexual behaviors (condom use, sex with unsteady partners and status disclosure).

McNemar's test was used to asses treatment effects of the intervention on sound knowledge, categorical scores of attitude and categorical sexual behavior practices related to HIV in the present study. It was carried out for changes at 2 months and 6 months.

Mixed design ANOVA was employed to determine the main effects of age, gender, group, time and group - time interaction effects for mean log scores of HIV knowledge, log attitude scores towards HIV/AIDS and log HIV status disclosure scores of the 3 study groups. Friedman's repeated measure ANOVA was used to look at main effects of group, time and group and time interaction effects of the median condom use scores of the 3 study groups. A partial eta square (ἠ2) as a measure of effect size representing the variance in proportions of the dependent variable that can be explained by the independent variable was applied to both mixed design ANOVA and Friedman's repeated measures ANOVA. The interpretation of the strength of eta squared values followed guidelines by Cohen, 1988: small effect (0.01), moderate effect (0.06) and large effect (0.14).

All results of log transformed data considered underlying data transformation during result interpretation. The confidence interval was set at 95% for mean estimations. The level of significance; alpha (α) was set at 0.05. A p value of less than 0.05 pertains to the decision rule. The decision rule used was to reject the null hypothesis when p was less than 0.05.

Conditions
HIV
Being tested
Clinician Client Centered (CCC) Counseling
Keywords
Adult HIV patients, Knowledge, Attitudes, Sexual behaviors
Medical subject headings
Behavior, Coitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinician Client Centered (CCC) CounselingBehavioural

    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.

Study groups in NCT02416648
Study groupRoleWhat they receive
CCC Counseling; baseline and 2 monthsExperimentalIntervention 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.
Receives: Behavioral: Clinician Client Centered (CCC) Counseling
CCC Counseling; baselineExperimentalIntervention 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.
Receives: Behavioral: Clinician Client Centered (CCC) Counseling
Routine careNo interventionThe control group received routine clinic care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2015 (estimated)
  2. Study startJan 2014
  3. Primary completionSep 2014
  4. Study completionSep 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
386 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02416648
Sponsor's protocol ID
Uputra
Status last verified
Apr 2015
First submitted
23 Mar 2015
Last updated
15 Apr 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Clinician Client Centered (CCC) Counseling in people with HIV, run by Universiti Putra Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Knowledge on HIV prevention and transmission (time frame: Change from baseline knowledge on HIV prevention and transmission at 2 months and at 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2015.

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