Table 3 Issues and constraints to SoC package implementation

STI services for trial participants

Many trial participants do not receive the results of laboratory STI tests at their next scheduled visit

Some participants do not receive appropriate and timely additional treatment as indicated by their STI laboratory test results

Team meetings involving clinic and data management staff suggest these issues arose due to a combination of: difficulty tracing participants in the community to ask them to return for further treatment; difficulty ensuring continuity of care between visits due to high clinic through-put and multiple clinical staff (participants not assigned designated clinician); and inadequate systems and procedures to flag new test results (so that even when participants did return to clinic and STI test results were present in their study folder, appropriate treatment was not always given)

Systems for reporting STI tests were reviewed and modified Feb 08 to shorten turnaround time between testing and release of results to clinic

Reporting system modified to expedite the printing of all positive laboratory results and their prompt release to clinicians resulting in targeted community follow-up e.g. participants requiring additional treatment following initial syndromic-based STI management

Clinical tools developed to facilitate continuity of care training of clinicians modified to emphasize the importance of full review and continuity of care at each clinical visit

STI services for sexual partners

Trial participants complained that although they are being treated for STIs at study clinics they are at risk of re-infection because their sexual partners refuse to attend STI referral services

A review of referral service utilisation in Jan07 (based on an internal review of trial records and referral centre notification slips) indicated poor uptake by male sexual partners (< 30%)

Trial participants have continued to request that sexual partners receive treatment in study clinics rather than by referral

An internal review conducted in Jan 2007 concluded that systems for monitoring and evaluating service uptake be strengthened; that staff at the referral centre receive regular updates on the trial and training in relevant trial procedures (e.g. adverse event reporting in men); and that a greater focus be placed on male participation and support for the trial through community outreach activities. Despite implementing these initiatives, estimated service uptake remained < 30% in the year to Jul 2008.

The issue of treating partners at study clinics has been explored several times in CAC and SAG meetings with the consensus view that study clinics have been established as 'a service for women provided by women' and that treating men at the same clinics would impact negatively on women's experience of clinic attendance and the trial.

Care and support for women living with HIV

A review of referral service utilisation in Jan07 (based on an internal review of trial records and referral centre notification slips) indicated poor uptake among women referred to the local collaborating specialist provider (< 30%)

During an internal review in Jan07, clinic staff were advised to emphasise the positive aspects of referral and to reaffirm that antiretroviral therapy can produce dramatic improvements in health and quality of life, even among those who present relatively late. Additional counselling and support were also offered to facilitate uptake but despite these measures, estimated service uptake remained < 30% in mid-2008.

Informal discussions with community representatives at workshops and CAC meetings have highlighted a number of potential constraints to service uptake, including stigma, travel and opportunity costs. These issues are being investigated in the Barriers Study that will inform local and national policy on ART access among vulnerable at-risk groups.

Gynaecology, general medical and child health

All women with suspected cervical carcinoma and/or other gynaecological abnormalities on speculum examination have to date received specialist care in Mwanza

It has not been possible to track general medical and child health service uptake.

Trial participants have continued to request that children receive treatment in study clinics rather than by referral

A new Breast and Cervical Cancer Screening Clinic is being established at a tertiary care hospital in Mwanza in 2009.

Plans to implement visual inspection with acetic acid (VIA) in Dar es Salaam and Mwanza are on-going (K Shapiro, personal communication)

Better systems for tracking service uptake following referral are required in future clinical trials in Mwanza.

CAC and SAG meetings have discussed service provision for children periodically during the trial but on each occasion have accepted that a combination of logistical, funding, human resource, sustainability and other issues make it difficult for the MDP301 Mwanza trial team to provide child health services directly via study clinics. All parties have agreed that this issue be carefully assessed in future trial design.