Table 1

MDP301 Mwanza clinical care package

Eligibility criteria: summary of those eligible to receive clinical care package provided through study clinics and referral services

All current MDP301 trial participants (scheduled clinical review as per trial protocol plus drop-in visits at any time)

All women who attended a screening visit for the MDP301 trial but were subsequently excluded or decided not to enrol (drop-in visits at any time)

All women who participated in the MDP Mwanza feasibility or pilot study (drop in visits at any time)

Male sexual partners of any of the above women were eligible for STI referral services

Summary of care provided in study clinics and via referral services

Management of STIs/RTIs

Syndromic STI management (based on national guidelines produced by the MoH in Tanzania[36]) supplemented by vaginal pH for bacterial vaginosis and collection of genital specimens and venepuncture according to trial Standard Operating Procedures (SOPs)

Clinical management subsequently adjusted as appropriate at next clinic visit based on laboratory test results (N. gonorrhoeae, C. trachomatis, T. vaginalis, Herpes simplex type-2, syphilis, bacterial vaginosis)

Sexual partners are advised to attend a designated collaborating local service provider for free STI care (women provided with referral slips; anonymised notification sent to a designated local STI care service provider)

HIV diagnosis and care

Voluntary HIV testing and counselling (VCT): same-day service using parallel rapid diagnostic tests supplemented by laboratory-based ELISA confirmation as appropriate and as specified in site SOPs

Women found to be HIV seropositive at the MDP301 screening visit, who seroconvert during the trial or who were diagnosed as HIV seropositive during the feasibility study are referred to a local collaborating specialist centre providing free HIV clinical care and support, including CD4 count estimation, diagnosis and management of tuberculosis and opportunistic infections, antiretroviral drug therapy and clinical monitoring

Counselling and support for women found to be HIV positive is provided at study clinics and via a local referral network established with CBOs and NGOs in Mwanza through the community liaison system. Free specialist support for women living with HIV is also available through this network e.g. legal advice regarding land and housing issues and related permanency arrangements

Family planning

Free counselling and advice regarding different forms of family planning are provided in study clinics, which also provide condoms, combined oral contraceptives and Depo-Provera injections as appropriate

Women requesting tubal ligation or intrauterine contraceptive devices (IUCD) are referred to local designated service providers

Gynaecology, general medical and child health services

General medical and genital examinations are conducted in all subjects at the MDP301 screening visit. Genital examination is subsequently scheduled at three-monthly intervals in the MDP301 trial protocol. General and genital examinations are also available as indicated at any time

Women found to have a gynaecological abnormality (e.g. suspected carcinoma of the cervix identified macroscopically on speculum examination) are referred to a designated specialist who provides expedited care on a private patient basis. Referral costs are routinely met by the study. Summary medical reports are provided to the study team for filing in patient clinical record folders

Women found to have a general medical condition (e.g. hypertension, diabetes) are referred to one of several local physicians. Referral costs are met by the study as required

Participants requesting services or advice for their children (e.g. for childhood fever or other medical conditions) are advised to attend free local child health clinics for assessment and clinical management and are not treated for malaria or other conditions at MDP Mwanza study clinics

Vallely et al. BMC Medical Ethics 2009 10:17   doi:10.1186/1472-6939-10-17

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