EXPERIENCES FROM RECIPROCAL MONITORING SCHEME IN EAST AFRICA.

Article by: Sarah Coutinho (CRA)

Monitoring is a key aspect of all kinds of research to ensure studies are conducted in compliance with the protocol, ICH-GCP guidelines, and local regulatory requirements.

The purpose of monitoring is to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents.

EAST AFRICAN POINT OF CARE VIRAL LOAD (EAPoC- VL) Study seeks to examine the feasibility, acceptability, and effectiveness of using point-of-care viral load monitoring to improve viral load suppression among children, adolescents, and young people living with HIV in East Africa.

The study has been conducted in four East African countries since 2022.

The countries involved are Kenya (KEMRI), Tanzania (NMRI, KCRI, and AIGHD/MDH), Rwanda (UoR), and Uganda (MRC/UVRI&LSHTH)

 The study has a total of 28 study sites randomized to either intervention or control in the ratio of 1:1.

Kenya has 4 sites: control sites are Ahero sub-county hospital, and Lumumba sub-county. Intervention sites: Rabour sub-county hospital, Jaramogi Oginga Teaching and Referral Hospital (JOOTR).

Rwanda has 4 sites: Control sites are, WE- ACT x for Hope, Kacyiru HC and Intervention sites KaguguHC and Remera HC

Tanzania has 12 sites: Control sites are: Consolata Sister's dispensary, Mount Meru Hospital Arusha- , Mnanzi Moja Hospital Mnanzi Moja Hospital. Intervention sites are: Mbagala Rangi Tatu Hospital, Kaloleni Health Centre, Majengo Health center Moshi, Mawenzi Hospital Moshi, , Amana Regional Referral Hospital.

Uganda has 8 sites: Ugandan control sites are: Uganda Cares Masaka, TASO Entebbe, TASO Mulago, Family Hope Jinja and Nsambya Home Care.  Intervention sites are TASO Masaka, TASO Jinja, Mildmay Uganda and TASO Jinja.

Monitors under EACCR- RMS in the four East African countries were involved in the monitoring activities.  They were assigned to various sites in different countries. Protocol training sessions were conducted before the start of the study to ensure study teams were well conversant with the study protocol, procedures, and SOPs.

Monitors were required to have at least 3-4 monitoring visits done as per the plan, for each site to ensure that the study progressed well with enrollment, follow up, Focus Group Discussions (FGD) and In-Depth Interviews (IDI).

• Most sites have been monitored at least twice and reports generated with query reports attached for follow up.
• All sites have managed to enroll the minimum required sample size and follow up and participants exits are ongoing to date.
• Sites have endeavored to address the queries identified during the visits and monitors discussed about the Corrective and Preventive Actions (CAPA) with the study teams.
• Sites have endeavored to maintain participants retention in the study by providing ongoing counselling during the follow up visits about the future benefits of the study.

Some challenges encountered during monitoring:

• Delayed recruitment due to inadequately eligible participants within the community cohorts.

• Study personnel at some sites lacked GCP training, however, recommendations were made to the country's Principal Investigators(PIs), and face-to-face GCP training was organized in all countries.

Monitoring is a key aspect of research, as it guides in following the approved protocol, GCP Guidelines and minimizing protocol violations/deviations.