Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202609741302558 Date of Registration: 04/09/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Helping people living with HIV remain in care and stay healthy: through testing counselling and support programmes in Rivers State.
Official scientific title Effectiveness of Enhanced Adherence Counseling and PsychoSocial support on HIV client reengagement and clinical outcomes across the Continuum of care in Rivers State. Nigeria - A Randomized Control Trial.
Brief summary describing the background and objectives of the trial Background: Despite free antiretroviral therapy, many people living with HIV in Rivers State disengage from care, leading to poor clinical outcomes such as low viral suppression, declining CD4 counts, anemia, and increased mortality. Standard adherence counselling alone has not been sufficient to address re-engagement and retention across the continuum of care. There is limited local evidence on whether enhanced adherence counselling and psychosocial support, compared to standard care, can improve re-engagement, retention, and health outcomes. In addition, the factors that drive disengagement and re-engagement in this setting, and the cost of delivering these interventions, remain poorly understood. This trial is therefore needed to generate evidence to guide HIV programming and policy in Rivers State and Nigeria. *Objectives* *Aim*: To evaluate the effectiveness of standard adherence counselling, enhanced adherence counselling, and psychosocial support on HIV client re-engagement and clinical outcomes across the continuum of care among people living with HIV in Rivers State, Nigeria. Aim (Primary Objective) To evaluate the effectiveness of standard enhanced adherence counselling and psychosocial support on HIV client re-engagement and clinical outcomes across the continuum of care among people living with HIV in Rivers State, Nigeria. Secondary Objectives 1)To compare the effect of the intervention on viral load suppression at 6 months, 8 months and 12 months. 2)To assess the effect of the combined interventions on patients’ re-engagement and retention in care at 6 months and 12 months. 3)To evaluate the effect of the combined interventions on: a. Hemoglobin levels from baseline (pre) to 6 months and 12 months (post) interventions. b. Body Mass Index (BMI) from baseline (pre) to 6 months and 12 months (post) interventions. c. Mean Cell Volume (MCV) levels from baseline to 6 months and 12 months (post) interventions. 4)To determine the proportion of participants who achieve good adherence (>95%) at 6–12 months. 5)To assess the effective adherence counselling strategies. 6)To determine the socio-demographic, clinical, psychosocial determinants/factors associated with disengagement and re-engagement in HIV care in Rivers State, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) N.A
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Psychosocial
Anticipated trial start date 15/09/2026
Actual trial start date
Anticipated date of last follow up 01/03/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 116
Actual target sample size (number of participants) 116
Recruitment status Not yet recruiting
Publication URL Not Applicable
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Standard of care Monthly routine clinic visits as per national guidelines. 3 months Participants will receive Standard ART and routine adherence counselling only. No enhanced counselling or psycho- social support 56 Active-Treatment of Control Group
Experimental Group Enhanced Adherence counselling 5 sessions per weeks psychosocial support and EAC as specified in protocol 3months Participants will receive Standard ART plus Enhanced Adherence Counseling and PsychoSocial support to improve HIV Client re-engagement and retention 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Inclusion Criteria 1. Participants must be male or female at least 18 years old and above. 2. Participants must have been on ART for at least 6 months. 3. Participants must have experienced challenges like missing doses or appointments or have not attended visits for at least 3 months. 4. Willing to provide written informed consent. Exclusion Criteria 1.Pregnant and lactating women will be excluded due to potential changes in treatment regimen. 2.Individuals with severe mental ill health and significant cognitive impairments will be excluded due to potential challenges understanding and participating in the study. 3.Individuals who have previously received Enhanced Adherence Counselling will be excluded to avoid potential biases and ensure that the study evaluates the effectiveness of Enhanced Adherence Counselling and Psychosocial Support in a naïve population. 4.Critically ill patients. 5.Individuals with severe psychiatric disorders impairing participation. 6.Participants unwilling to provide consent. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 79 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 20/07/2026 Ethics and Research Committee
Ethics Committee Address
Street address City Postal code Country
East-west Road, opposite Alakahia Junction Port Harcourt 6173 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Outcomes : Primary outcomes: Viral suppression Re-engagement in care and Retention. We have Baseline,at 6 months,8months and 12 months respectively
Secondary Outcome Secondary outcomes Clinical outcomes for Hemoglobin Estimation, Body Mass index and Mean cell volume We have Baseline,at 6 months,8months and 12 months respectively
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Port Harcourt Teaching Hospital East-West Road, Opposite Alakahia Junction Port Harcourt 6173 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Opara Chinwendu Jane Chief Benson Alikor street off LARRITEL Hotel Junction by Odarawere road Port Harcourt 500272 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Opara Chinwendu Jane Chief Benson Alikor street off LARRITEL Hotel Junction by Odarawere road Port Harcourt 500272 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
University of Port Harcourt School of Public Health. Abuja Park, University of Port Harcourt Port Harcourt 6173 Nigeria
University of Port Harcourt Teaching Hospital East-West Road, Opposite Alakahia Junction, Rivers State Port Harcourt 6173 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries Opara Chinwendu Jane noblecare967@gmail.com +2348035127221 Chief Benson Alikor street off LARRITEL Hotel Junction by Odarawere road
City Postal code Country Position/Affiliation
Port Harcourt 500272 Nigeria School of public health
Role Name Email Phone Street address
Principal Investigator Tobin West drtobinwest@gmail.com +2348033170115 East-west road, Choba
City Postal code Country Position/Affiliation
Port Harcourt 500004 Nigeria School of Public Health
Role Name Email Phone Street address
Scientific Enquiries Tobin West drtobinwest@gmail.com +2348033170115 East-West Road, Choba
City Postal code Country Position/Affiliation
Port Harcourt 500004 Nigeria School of public health
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Anonymized demographic and baseline characteristics, intervention allocation, adherence-related measures, psychosocial assessment data, and study outcomes/follow-up data collected over 3 months. Study Protocol 6 months after main paper results Key IPD Access Criteria: 1. Scientific Rationale: Requester must provide a methodologically sound proposal with specific aims and analysis plan. 2. Ethics Approval: Requester must provide evidence of ethics approval from their institution for the proposed use of the data. 3. Data Use Agreement: Requester must sign a Data Use Agreement prohibiting re-identification of participants and re-sharing of data. 4. Authorship Policy: Requester must acknowledge the original study team in any publications and offer co-authorship if there is substantial intellectual contribution. 5. No Commercial Use: Data will not be used for commercial purposes without prior written agreement. 6. Timeline: Data will be available for 5 years after initial sharing.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
ClinicalTrials.gov No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 27/08/2026 Corrected Group Size and name to match sample size of 116 as requested by PACTR reviewer. Control Group, Enhanced Adherence Counselling, 3 sessions per week EAC: as specified in protocol, 3 months, Participants will receive Enhanced Adherence Counselling, delivered in 3 sessions per week for 3 months., 30, Active-Treatment of Control Group Control Group, Standard of care, Monthly routine clinic visits as per national guidelines., 3 months, Participants will receive Standard ART and routine adherence counselling only. No enhanced counselling or psycho- social support, 56, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 27/08/2026 Corrected Group Size and name to match sample size of 116 as requested by PACTR reviewer. Experimental Group, Enhanced Adherence counselling and psychosocial support , 3 sessions per weeks psychosocial support and EAC, 3months, Participants receive Enhanced Adherence counselling together with structured psycho social support aimed at improving adherence and addressing Psychosocial barriers., 30, Experimental Group, Enhanced Adherence counselling, 5 sessions per weeks psychosocial support and EAC as specified in protocol , 3months, Participants will receive Standard ART plus Enhanced Adherence Counseling and PsychoSocial support to improve HIV Client re-engagement and retention , 60,