Short summary

Connected to Care aims to improve the follow-up of women who attend cervical cancer screening and test HPV-positive in Dar es Salaam and Moshi, Tanzania. The project has three sub studies:

1. A Randomized Controlled Trial among HPV-positive women who are randomized to:
1. Standard care plus an mHealth intervention that includes health messages/quizzes about cervical cancer/screening and sms-reminders of next screening visit, or
2. Standard care.
2. An assessment of the cost-effectiveness of the intervention.
3. An evaluation of the acceptability of study participation.

The study is part of the five-year research project Comprehensive Cervical Cancer Prevention in Tanzania (CONCEPT).

Rationale

Background

Globally, cervical cancer is the fourth most common cancer disease among women with more than 530.000 new cases every year, and more than 265.000 women die each year due to this disease. In Tanzania, cervical cancer accounts for 38.4% (n=7300) and 34.3% (n=4200) of all cancers and cancer-related deaths among women, respectively. Persistent High-Risk (HR) Human Papilloma Virus (HPV) infection is a necessary first step in order to develop cervical cancer. In a recent study, the prevalence of HR HPV was 20.1% in Tanzania, and among women who were HIV-positive the prevalence was 46.7%. Cervical cancer often affects women at reproductive age, who are breadwinners and family caretakers. Thus, it is a public health concern with enormous social and economic impact. Screening programmes can be efficient tools to reduce the number of cervical cancer cases, but they are difficult to maintain due to low knowledge of cervical cancer and low acceptance of screening programmes, especially in Low Income Countries (LIC).

In Africa, mobile accessibility has increased exceptionally in the past decade, and mobile possession is high. Hence, 88% of women, who attended cervical cancer screening at Kilimanjaro Christian Medical Centre (KCMC) in January 2015, had access to a cell phone (personal communication). Mobile Health (mHealth) interventions have proved to be an innovative and effective tool to tackle health issues in LIC. In Kenya, a Randomised Clinical Trial (RCT) showed that SMS-reminders increased adherence to antiretroviral therapy with 12% compared to controls, while a RCT in Zanzibar showed SMS-reminders and a phone voucher increased skilled delivery attendance with 13% compared to controls. A Cost-Effective Analysis (CEA) of different recall-methods within cervical cancer among Malaysian women showed that SMS-reminders were the cheapest recall method compared to registered letters, postal letters, and phone call. However, phone call was the most cost-effective method to get women to repeat a pap smear.

The objective of this PhD-study is to assess the effect of the mobile phone intervention Connected to Care on the attendance rate to cervical cancer screening check-up appointments. Further, to assess the cost-effectiveness of the intervention and the acceptability of being Connected to Care.

Specific objectives

1. To assess the effect of mHealth messages, mHealth quizzes, and sms-reminders on HPV-positive women's attendance to check-up appointments at 14 months compared to standard of care.
2. To estimate the cost-effectiveness of Connected to Care compared to standard of care.
3. To explore HPV-positive women's acceptance of mHealth messages, mHealth quizzes, and sms-reminders.

Description of the cohort

The RCT study population consists of 950 HPV-positive women who are recruited through Ocean Road Cancer Institute (ORCI), Dar es Salaam and Kilimanjaro Christian Medical Centre (KCMC), Moshi, where the women attend cervical cancer screening and HIV care. As HIV-positive women are at increased risk of cervical cancer, this group is oversampled for the study. At the two study sites, 4000 women are screened for cervical cancer and tested for HR HPV during a nine months inclusion period; it is expected that 950 (25%) of the screened women test positive for HPV and that 410 (10%) out of the 950 women are also HIV-positive.

In order to pursue in-depth perspectives of acceptability, a qualitative study runs parallel to the RCT. The study site is Bagamoyo, which has the same cervical cancer screening programmes as ORCI and KCMC. However, it is a separate site in order not to interfere with the RCT. Twenty-five women who attend cervical cancer screening in Bagamoyo are purposely sampled for this study.

Data and biological material

All RCT participants fill out a questionnaire at baseline and at follow-up. The baseline questionnaire concerns socio-economic factors, lifestyle factors and health, sexual and reproductive health, knowledge of cervical cancer, and acceptance of mHealth messages. At follow-up participants will answer the same questions on knowledge of cervical cancer and acceptance of mHealth messages.

All study participants for the qualitative sub-study are treated as core cases and fill out the same baseline and follow-up questionnaire as the RCT. In the 14 month period in which they are Connected to Care in-depth interviews will be carried out with them in their local environment.

Collaborating researchers and departments

Ocean Road Cancer Institute (ORCI), Dar es Salaam, Tanzania Kilimanjaro Christian Medical Centre (KCMC), Moshi, Tanzania

Publications associated with the project

Text messages to increase attendance tofollow-up cervical cancer screeningappointments among HPV-positiveTanzanian women (Connected2Care): studyprotocol for a randomised controlled trial.  Ditte S. Linde, Marianne S. Andersen, Julius D. Mwaiselage, Rachel Manongi, Susanne K. Kjaer and Vibeke Rasch. Trials 2017 18:555